Cardiovascular Device Classification Codes

DXN Class 2

System, Measurement, Blood-Pressure, Non-Invasive

Clearances 1166

Regulation 21 CFR 870.1130

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DQY Class 2

Catheter, Percutaneous

Clearances 850

Regulation 21 CFR 870.1250

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DQX Class 2

Wire, Guide, Catheter

Clearances 735

Regulation 21 CFR 870.1330

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DQA Class 2

Oximeter

Clearances 702

Regulation 21 CFR 870.2700

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DYB Class 2

Introducer, Catheter

Clearances 659

Regulation 21 CFR 870.1340

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DPS Class 2

Electrocardiograph

Clearances 558

Regulation 21 CFR 870.2340

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DQO Class 2

Catheter, Intravascular, Diagnostic

Clearances 488

Regulation 21 CFR 870.1200

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DTB Class 3

Permanent Pacemaker Electrode

Clearances 487

Regulation 21 CFR 870.3680

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DXY Class 3

Implantable Pacemaker Pulse-Generator

Clearances 461

Regulation 21 CFR 870.3610

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DQK Class 2

Computer, Diagnostic, Programmable

Clearances 422

Regulation 21 CFR 870.1425

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MHX Class 2

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Clearances 403

Regulation 21 CFR 870.1025

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DSI Class 2

Detector And Alarm, Arrhythmia

Clearances 385

Regulation 21 CFR 870.1025

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DWF Class 2

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Clearances 378

Regulation 21 CFR 870.4210

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LIT Class 2

Catheter, Angioplasty, Peripheral, Transluminal

Clearances 374

Regulation 21 CFR 870.1250

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DRT Class 2

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Clearances 339

Regulation 21 CFR 870.2300

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DRX Class 2

Electrode, Electrocardiograph

Clearances 328

Regulation 21 CFR 870.2360

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JOW Class 2

Sleeve, Limb, Compressible

Clearances 328

Regulation 21 CFR 870.5800

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DXH Class 2

Transmitters And Receivers, Electrocardiograph, Telephone

Clearances 287

Regulation 21 CFR 870.2920

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MWI Class 2

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Clearances 273

Regulation 21 CFR 870.2300

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DTZ Class 2

Oxygenator, Cardiopulmonary Bypass

Clearances 241

Regulation 21 CFR 870.4350

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MKJ Class 3

Automated External Defibrillators (Non-Wearable)

Clearances 211

Regulation 21 CFR 870.5310

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DXT Class 2

Injector And Syringe, Angiographic

Clearances 197

Regulation 21 CFR 870.1650

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DXC Class 2

Clamp, Vascular

Clearances 196

Regulation 21 CFR 870.4450

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DSH Class 2

Recorder, Magnetic Tape, Medical

Clearances 192

Regulation 21 CFR 870.2800

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DSY Class 2

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Clearances 185

Regulation 21 CFR 870.3450

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DXQ Class 2

Blood Pressure Cuff

Clearances 185

Regulation 21 CFR 870.1120

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DRF Class 2

Catheter, Electrode Recording, Or Probe, Electrode Recording

Clearances 181

Regulation 21 CFR 870.1220

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DRG Class 2

Transmitters And Receivers, Physiological Signal, Radiofrequency

Clearances 180

Regulation 21 CFR 870.2910

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KRA Class 2

Catheter, Continuous Flush

Clearances 173

Regulation 21 CFR 870.1210

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DXG Class 2

Computer, Diagnostic, Pre-Programmed, Single-Function

Clearances 170

Regulation 21 CFR 870.1435

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DTN Class 2

Reservoir, Blood, Cardiopulmonary Bypass

Clearances 164

Regulation 21 CFR 870.4400

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LDD Class 2

Dc-Defibrillator, Low-Energy, (Including Paddles)

Clearances 164

Regulation 21 CFR 870.5300

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DSP Class 2

System, Balloon, Intra-Aortic And Control

Clearances 161

Regulation 21 CFR 870.3535

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DWJ Class 2

System, Thermal Regulating

Clearances 157

Regulation 21 CFR 870.5900

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DQD Class 2

Stethoscope, Electronic

Clearances 154

Regulation 21 CFR 870.1875

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DRS Class 2

Transducer, Blood-Pressure, Extravascular

Clearances 147

Regulation 21 CFR 870.2850

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QEW Class 2

Peripheral Mechanical Thrombectomy With Aspiration

Clearances 139

Regulation 21 CFR 870.5150

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DPW Class 2

Flowmeter, Blood, Cardiovascular

Clearances 135

Regulation 21 CFR 870.2100

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DTL Class 2

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Clearances 134

Regulation 21 CFR 870.4290

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MCW Class 2

Catheter, Peripheral, Atherectomy

Clearances 133

Regulation 21 CFR 870.4875

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LDF Class 2

Electrode, Pacemaker, Temporary

Clearances 127

Regulation 21 CFR 870.3680

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KRD Class 2

Device, Vascular, For Promoting Embolization

Clearances 114

Regulation 21 CFR 870.3300

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MSX Class 2

System, Network And Communication, Physiological Monitors

Clearances 112

Regulation 21 CFR 870.2300

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DSB Class 2

Plethysmograph, Impedance

Clearances 111

Regulation 21 CFR 870.2770

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NRY Class 2

Catheter, Thrombus Retriever

Clearances 105

Regulation 21 CFR 870.1250

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DSA Class 2

Cable, Transducer And Electrode, Patient, (Including Connector)

Clearances 104

Regulation 21 CFR 870.2900

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DTD Class 2

Pacemaker Lead Adaptor

Clearances 102

Regulation 21 CFR 870.3620

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QJP Class 2

Catheter, Percutaneous, Neurovasculature

Clearances 100

Regulation 21 CFR 870.1250

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DYG Class 2

Catheter, Flow Directed

Clearances 99

Regulation 21 CFR 870.1240

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DTM Class 2

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Clearances 96

Regulation 21 CFR 870.4260

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DRE Class 2

Dilator, Vessel, For Percutaneous Catheterization

Clearances 95

Regulation 21 CFR 870.1310

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QEZ Class 2

Aspiration Thrombectomy Catheter

Clearances 94

Regulation 21 CFR 870.5150

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DTR Class 2

Heat-Exchanger, Cardiopulmonary Bypass

Clearances 91

Regulation 21 CFR 870.4240

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DSF Class 1

Recorder, Paper Chart

Clearances 87

Regulation 21 CFR 870.2810

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DXZ Class 2

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Clearances 85

Regulation 21 CFR 870.3470

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DRO Class 2

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Clearances 84

Regulation 21 CFR 870.5550

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KFM Class 2

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Clearances 84

Regulation 21 CFR 870.4360

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MJN Class 2

Catheter, Intravascular Occluding, Temporary

Clearances 84

Regulation 21 CFR 870.4450

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DTK Class 2

Filter, Intravascular, Cardiovascular

Clearances 79

Regulation 21 CFR 870.3375

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DXK Class 2

Echocardiograph

Clearances 78

Regulation 21 CFR 870.2330

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LOX Class 2

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Clearances 78

Regulation 21 CFR 870.5100

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DSK Class 2

Computer, Blood-Pressure

Clearances 75

Regulation 21 CFR 870.1110

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MNW Class 2

Analyzer, Body Composition

Clearances 75

Regulation 21 CFR 870.2770

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KRH Class 2

Ring, Annuloplasty

Clearances 74

Regulation 21 CFR 870.3800

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DXE Class 2

Catheter, Embolectomy

Clearances 73

Regulation 21 CFR 870.5150

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OBJ Class 2

Catheter, Ultrasound, Intravascular

Clearances 73

Regulation 21 CFR 870.1200

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DXJ Class 2

Display, Cathode-Ray Tube, Medical

Clearances 72

Regulation 21 CFR 870.2450

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DWS Class 1

Instruments, Surgical, Cardiovascular

Clearances 71

Regulation 21 CFR 870.4500

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JOP Class 2

Transducer, Ultrasonic

Clearances 71

Regulation 21 CFR 870.2880

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NLH Class 2

Catheter, Recording, Electrode, Reprocessed

Clearances 69

Regulation 21 CFR 870.1220

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QEY Class 2

Mechanical Thrombolysis Catheter

Clearances 69

Regulation 21 CFR 870.5150

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MUD Class 2

Oximeter, Tissue Saturation

Clearances 66

Regulation 21 CFR 870.2700

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DTE Class 2

Pulse-Generator, Pacemaker, External

Clearances 64

Regulation 21 CFR 870.3600

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MWJ Class 2

Electrocardiograph, Ambulatory (Without Analysis)

Clearances 62

Regulation 21 CFR 870.2800

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DXO Class 2

Transducer, Pressure, Catheter Tip

Clearances 59

Regulation 21 CFR 870.2870

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MAV Class 2

Syringe, Balloon Inflation

Clearances 53

Regulation 21 CFR 870.1650

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PDU Class 2

Catheter For Crossing Total Occlusions

Clearances 53

Regulation 21 CFR 870.1250

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JOM Class 2

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Clearances 51

Regulation 21 CFR 870.2780

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DRC Class 2

Trocar

Clearances 49

Regulation 21 CFR 870.1390

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DTQ Class 2

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Clearances 48

Regulation 21 CFR 870.4220

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DRY Class 2

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Clearances 45

Regulation 21 CFR 870.4330

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DPT Class 2

Probe, Blood-Flow, Extravascular

Clearances 44

Regulation 21 CFR 870.2120

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DRM Class 2

Compressor, Cardiac, External

Clearances 44

Regulation 21 CFR 870.5200

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KRI Class 1

Accessory Equipment, Cardiopulmonary Bypass

Clearances 42

Regulation 21 CFR 870.4200

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PNO Class 2

Catheter, Percutaneous, Cutting/Scoring

Clearances 41

Regulation 21 CFR 870.1250

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DRA Class 2

Catheter, Steerable

Clearances 40

Regulation 21 CFR 870.1280

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MOF Class 2

Guide, Wire, Catheter, Neurovasculature

Clearances 40

Regulation 21 CFR 870.1330

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DWA Class 2

Control, Pump Speed, Cardiopulmonary Bypass

Clearances 37

Regulation 21 CFR 870.4380

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KRB Class 2

Probe, Thermodilution

Clearances 37

Regulation 21 CFR 870.1915

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DTP Class 2

Defoamer, Cardiopulmonary Bypass

Clearances 34

Regulation 21 CFR 870.4230

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DRN Class 2

Device, Counter-Pulsating, External

Clearances 33

Regulation 21 CFR 870.5225

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MLO Class 2

Electrocardiograph, Ambulatory, With Analysis Algorithm

Clearances 32

Regulation 21 CFR 870.2800

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MTD Class 2

Catheter, Intracardiac Mapping, High-Density Array

Clearances 32

Regulation 21 CFR 870.1220

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NTE Class 2

Temporary Carotid Catheter For Embolic Capture

Clearances 32

Regulation 21 CFR 870.1250

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OWQ Class 2

Reprocessed Intravascular Ultrasound Catheter

Clearances 31

Regulation 21 CFR 870.1200

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DTC Class 2

Analyzer, Pacemaker Generator Function

Clearances 30

Regulation 21 CFR 870.3630

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MXD Class 2

Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Clearances 30

Regulation 21 CFR 870.1025

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DWC Class 2

Controller, Temperature, Cardiopulmonary Bypass

Clearances 29

Regulation 21 CFR 870.4250

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LDE Class 1

Stethoscope, Manual

Clearances 28

Regulation 21 CFR 870.1875

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MMX Class 2

Device, Percutaneous Retrieval

Clearances 28

Regulation 21 CFR 870.5150

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DRB Class 2

Stylet, Catheter

Clearances 27

Regulation 21 CFR 870.1380

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NLF Class 2

Oximeter, Reprocessed

Clearances 27

Regulation 21 CFR 870.2700

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DXX Class 2

System, Catheter Control, Steerable

Clearances 26

Regulation 21 CFR 870.1290

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DQR Class 2

Cannula, Catheter

Clearances 25

Regulation 21 CFR 870.1300

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DRQ Class 2

Amplifier And Signal Conditioner, Transducer Signal

Clearances 25

Regulation 21 CFR 870.2060

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KRG Class 3

Programmer, Pacemaker

Clearances 25

Regulation 21 CFR 870.3700

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MGZ Class 2

Valvulotome

Clearances 25

Regulation 21 CFR 870.4885

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DRR Class 2

Amplifier And Signal Conditioner, Biopotential

Clearances 24

Regulation 21 CFR 870.2050

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KRJ Class 2

Filter, Prebypass, Cardiopulmonary Bypass

Clearances 24

Regulation 21 CFR 870.4280

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NCX Class 2

System, Hypothermia, Intravenous, Cooling

Clearances 24

Regulation 21 CFR 870.5900

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DWZ Class 2

Device, Biopsy, Endomyocardial

Clearances 23

Regulation 21 CFR 870.4075

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IZQ Class 2

Injector, Contrast Medium, Automatic

Clearances 23

Regulation 21 CFR 870.1650

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MXC Class 2

Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Clearances 22

Regulation 21 CFR 870.2800

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NFA Class 2

Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Clearances 22

Regulation 21 CFR 870.1250

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DWB Class 2

Pump, Blood, Cardiopulmonary Bypass, Roller Type

Clearances 21

Regulation 21 CFR 870.4370

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DYF Class 2

Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Clearances 21

Regulation 21 CFR 870.3450

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DWP Class 2

Dilator, Vessel, Surgical

Clearances 20

Regulation 21 CFR 870.4475

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DXF Class 2

Catheter, Septostomy

Clearances 20

Regulation 21 CFR 870.5175

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DWE Class 2

Tubing, Pump, Cardiopulmonary Bypass

Clearances 19

Regulation 21 CFR 870.4390

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QYX Class 2

Outpatient Cardiac Telemetry

Clearances 19

Regulation 21 CFR 870.1025

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DQC Class 1

Phonocardiograph

Clearances 18

Regulation 21 CFR 870.2390

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DQE Class 2

Catheter, Oximeter, Fiber-Optic

Clearances 18

Regulation 21 CFR 870.1230

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DRL Class 2

Tester, Defibrillator

Clearances 18

Regulation 21 CFR 870.5325

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DWM Class 2

Apparatus, Suction, Patient Care

Clearances 18

Regulation 21 CFR 870.5050

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JOQ Class 2

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

Clearances 18

Regulation 21 CFR 870.1750

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DTW Class 2

Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

Clearances 16

Regulation 21 CFR 870.4340

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LIX Class 2

Aid, Cardiopulmonary Resuscitation

Clearances 16

Regulation 21 CFR 870.5210

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DWD Class 2

Suction Control, Intracardiac, Cardiopulmonary Bypass

Clearances 15

Regulation 21 CFR 870.4430

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DWX Class 2

Stripper, Artery, Intraluminal

Clearances 14

Regulation 21 CFR 870.4875

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KRL Class 2

Detector, Bubble, Cardiopulmonary Bypass

Clearances 14

Regulation 21 CFR 870.4205

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MLD Class 2

Monitor, St Segment With Alarm

Clearances 14

Regulation 21 CFR 870.1025

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PPN Class 2

Percutaneous Catheter, Ultrasound

Clearances 14

Regulation 21 CFR 870.1250

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DXS Class 2

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Clearances 13

Regulation 21 CFR 870.4310

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KRE Class 2

Analyzer, Pacemaker Generator Function, Indirect

Clearances 13

Regulation 21 CFR 870.3640

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OZT Class 2

Balloon Aortic Valvuloplasty

Clearances 13

Regulation 21 CFR 870.1255

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DQT Class 2

Occluder, Catheter Tip

Clearances 12

Regulation 21 CFR 870.1370

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DTJ Class 1

Holder, Heart-Valve, Prosthesis

Clearances 12

Regulation 21 CFR 870.3935

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JOD Class 2

Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

Clearances 12

Regulation 21 CFR 870.4270

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QME Class 2

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Clearances 12

Regulation 21 CFR 870.2785

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DPZ Class 2

Oximeter, Ear

Clearances 11

Regulation 21 CFR 870.2710

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KRC Class 2

Tester, Electrode, Surface, Electrocardiographic

Clearances 11

Regulation 21 CFR 870.2370

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PSQ Class 2

Intracardiac Patch Or Pledget, Biologically Derived

Clearances 11

Regulation 21 CFR 870.3470

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DTA Class 2

Tester, Pacemaker Electrode Function

Clearances 10

Regulation 21 CFR 870.3720

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DTX Class 2

Gas Control Unit, Cardiopulmonary Bypass

Clearances 10

Regulation 21 CFR 870.4300

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OMR Class 2

Vessel Guard Or Cover

Clearances 10

Regulation 21 CFR 870.3470

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DQI Class 2

Withdrawal/Infusion Pump

Clearances 9

Regulation 21 CFR 870.1800

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DTS Class 2

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Clearances 9

Regulation 21 CFR 870.4420

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KRK Class 2

Manometer, Blood-Pressure, Venous

Clearances 9

Regulation 21 CFR 870.1140

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OBH Class 2

Monitor, Extracellular Fluid, Lymphedema, Extremity

Clearances 9

Regulation 21 CFR 870.2770

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DRW Class 2

Adaptor, Lead Switching, Electrocardiograph

Clearances 8

Regulation 21 CFR 870.2350

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DSS Class 2

Clip, Vascular

Clearances 8

Regulation 21 CFR 870.3250

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DTY Class 2

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Clearances 8

Regulation 21 CFR 870.4410

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DWQ Class 2

Stripper, Vein, External

Clearances 8

Regulation 21 CFR 870.4885

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MJJ Class 2

Cpb Check Valve, Retrograde Flow, In-Line

Clearances 8

Regulation 21 CFR 870.4400

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PJA Class 2

Coronary Vascular Physiologic Simulation Software

Clearances 8

Regulation 21 CFR 870.1415

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PLA Class 2

Esophageal Thermal Regulation And Gastric Suctioning Device

Clearances 8

Regulation 21 CFR 870.5910

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QDA Class 2

Electrocardiograph Software For Over-The-Counter Use

Clearances 8

Regulation 21 CFR 870.2345

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QNR Class 2

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

Clearances 8

Regulation 21 CFR 870.4100

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DTI Class 1

Sizer, Heart-Valve, Prosthesis

Clearances 7

Regulation 21 CFR 870.3945

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NAJ Class 2

Agents, Embolic, For Treatment Of Uterine Fibroids

Clearances 7

Regulation 21 CFR 870.3300

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OGZ Class 2

Catheter, Intravascular, Plaque Morphology Evaluation

Clearances 7

Regulation 21 CFR 870.1200

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PLB Class 2

Multivariate Vital Signs Index

Clearances 7

Regulation 21 CFR 870.2300

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PNE Class 2

Reprocessed Catheter Introducer

Clearances 7

Regulation 21 CFR 870.1340

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PPW Class 2

Adjunctive Cardiovascular Status Indicator

Clearances 7

Regulation 21 CFR 870.2200

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MAL Class 2

Graft, Vascular, Synthetic/Biologic Composite

Clearances 6

Regulation 21 CFR 870.3450

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NZE Class 2

Hyperthermia Monitor

Clearances 6

Regulation 21 CFR 870.5900

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QNL Class 2

Medium-Term Adjunctive Predictive Cardiovascular Indicator

Clearances 6

Regulation 21 CFR 870.2210

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DTG Class 1

Magnet, Test, Pacemaker

Clearances 5

Regulation 21 CFR 870.3690

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DXR Class 2

Ballistocardiograph

Clearances 5

Regulation 21 CFR 870.2320

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DXW Class 2

System, Phonocatheter, Intracavitary

Clearances 5

Regulation 21 CFR 870.1270

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NVM Class 2

Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

Clearances 5

Regulation 21 CFR 870.1250

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OMZ Class 2

Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter

Clearances 5

Regulation 21 CFR 870.1250

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PQK Class 2

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Clearances 5

Regulation 21 CFR 870.1252

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QYE Class 2

Reduced Ejection Fraction Machine Learning-Based Notification Software

Clearances 5

Regulation 21 CFR 870.2380

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DRI Class 1

Monitor, Line Isolation

Clearances 4

Regulation 21 CFR 870.2620

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DRJ Class 1

System, Signal Isolation

Clearances 4

Regulation 21 CFR 870.2600

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DSJ Class 2

Alarm, Blood-Pressure

Clearances 4

Regulation 21 CFR 870.1100

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DYC Class 2

Vectorcardiograph

Clearances 4

Regulation 21 CFR 870.2400

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LHX Class 2

Trousers, Anti-Shock

Clearances 4

Regulation 21 CFR 870.5800

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MOP Class 1

Rotator, Prosthetic Heart Valve

Clearances 4

Regulation 21 CFR 870.3935

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MWS Class 1

Stabilizer, Heart

Clearances 4

Regulation 21 CFR 870.4500

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NQH Class 2

Sensor, Pressure, Aneurysm, Implantable

Clearances 4

Regulation 21 CFR 870.2855

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NUI Class 2

Ultrasound, Infusion, System

Clearances 4

Regulation 21 CFR 870.1200

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OTD Class 2

Endovascular Suturing System

Clearances 4

Regulation 21 CFR 870.3460

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PZS Class 2

Dual Lumen Ecmo Cannula

Clearances 4

Regulation 21 CFR 870.4100

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QAQ Class 2

Adjunctive Predictive Cardiovascular Indicator

Clearances 4

Regulation 21 CFR 870.2210

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QDB Class 2

Photoplethysmograph Analysis Software For Over-The-Counter Use

Clearances 4

Regulation 21 CFR 870.2790

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QJZ Class 2

Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Clearances 4

Regulation 21 CFR 870.4100

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QUO Class 2

Adjunctive Heart Failure Status Indicator

Clearances 4

Regulation 21 CFR 870.2200

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BYS Class 2

Oxygenator, Long Term Support Greater Than 6 Hours

Clearances 3

Regulation 21 CFR 870.4100

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DQB Class 2

Phlebograph, Impedance

Clearances 3

Regulation 21 CFR 870.2750

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DQF Class 2

Actuator, Syringe, Injector Type

Clearances 3

Regulation 21 CFR 870.1670

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DXL Class 2

Injector, Indicator

Clearances 3

Regulation 21 CFR 870.1660

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KFJ Class 3

Materials, Repair Or Replacement, Pacemaker

Clearances 3

Regulation 21 CFR 870.3710

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MAB Class 2

Marker, Cardiopulmonary Bypass (Vein Marker)

Clearances 3

Regulation 21 CFR 870.3450

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MPD Class 2

Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator

Clearances 3

Regulation 21 CFR 870.5300

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NLG Class 2

Catheter, Intracardiac Mapping, High-Density, Reprocessed

Clearances 3

Regulation 21 CFR 870.1220

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NMF Class 2

Clamp, Vascular, Reprocessed

Clearances 3

Regulation 21 CFR 870.4450

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NQG Class 1

Stabilizer, Heart, Non-Compression, Reprocessed

Clearances 3

Regulation 21 CFR 870.4500

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OAC Class 2

Plethysmograph, Air Displacement For Body Composition Analysis

Clearances 3

Regulation 21 CFR 870.2770

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OCR Class 2

Lung Sound Monitor

Clearances 3

Regulation 21 CFR 870.1875

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PJB Class 2

Catheter Remote Control System

Clearances 3

Regulation 21 CFR 870.5700

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QAF Class 2

Impedance Plethysmograph, Cranial

Clearances 3

Regulation 21 CFR 870.2770

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QEX Class 2

Coronary Mechanical Thrombectomy With Aspiration

Clearances 3

Regulation 21 CFR 870.5150

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QHW Class 2

Single Lumen Ecmo Cannula

Clearances 3

Regulation 21 CFR 870.4100

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QQI Class 2

Interventional Cardiovascular Implant Simulation Software Device

Clearances 3

Regulation 21 CFR 870.1405

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SAT Class 2

Pulmonary Hypertension Machine Learning-Based Notification Software

Clearances 3

Regulation 21 CFR 870.2380

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SDJ Class 2

Adjunctive Cardiac Amyloidosis Status Indicator

Clearances 3

Regulation 21 CFR 870.2200

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DTF Class 1

Tools, Pacemaker Service

Clearances 2

Regulation 21 CFR 870.3730

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DXM Class 2

Densitometer

Clearances 2

Regulation 21 CFR 870.1450

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DXP Class 2

Transducer, Vessel Occlusion

Clearances 2

Regulation 21 CFR 870.2890

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LXN Class 1

Probe, Test, Heart-Valve

Clearances 2

Regulation 21 CFR 870.4500

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MFX Class 2

Vessel Guard Or Cover, To Facilitate Revision Surgeries

Clearances 2

Regulation 21 CFR 870.3470

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MLC Class 2

Monitor, St Segment

Clearances 2

Regulation 21 CFR 870.2340

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MNJ Class 2

Valve, Pressure Relief, Cardiopulmonary Bypass

Clearances 2

Regulation 21 CFR 870.4400

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NDQ Class 2

System, Catheter Or Guidewire, Steerable (Magnetic)

Clearances 2

Regulation 21 CFR 870.1290

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NHW Class 2

Electrode, Pacing And Cardioversion, Temporary, Epicardial

Clearances 2

Regulation 21 CFR 870.3680

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NMD Class 2

Oximeter, Tissue Saturation, Reprocessed

Clearances 2

Regulation 21 CFR 870.2700

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OED Class 2

Antimicrobial Blood Pressure Cuff

Clearances 2

Regulation 21 CFR 870.1120

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OLK Class 2

Pulse Oximeter For Over-The-Counter Use

Clearances 2

Regulation 21 CFR 870.2700

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PAW Class 2

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Clearances 2

Regulation 21 CFR 870.3470

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PMK Class 1

Cpr Aid Device Without Feedback

Clearances 2

Regulation 21 CFR 870.5210

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PST Class 2

Aortic Annuloplasty Ring

Clearances 2

Regulation 21 CFR 870.3800

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PUM Class 2

Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

Clearances 2

Regulation 21 CFR 870.1251

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QEK Class 2

Angiographic Coronary Vascular Physiologic Simulation Software

Clearances 2

Regulation 21 CFR 870.1415

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QJB Class 2

Adjunct Monitor, Protein Calorie Malnutrition

Clearances 2

Regulation 21 CFR 870.2770

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QLZ Class 2

Septostomy Catheter, Reprocessed

Clearances 2

Regulation 21 CFR 870.5175

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QNV Class 2

Adjunctive Hemodynamic Indicator With Decision Point

Clearances 2

Regulation 21 CFR 870.2220

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SBQ Class 2

Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software

Clearances 2

Regulation 21 CFR 870.2380

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DQH Class 2

Cardiograph, Apex (Vibrocardiograph)

Clearances 1

Regulation 21 CFR 870.2310

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DRK Class 3

Dc-Defibrillator, High Energy, (Including Paddles)

Clearances 1

Regulation 21 CFR 870.5300

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DSM Class 1

Alarm, Leakage Current, Portable

Clearances 1

Regulation 21 CFR 870.2640

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DST Class 2

Clip, Vena-Cava

Clearances 1

Regulation 21 CFR 870.3260

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MFY Class 2

Endothelial Cell Harvesting Kit

Clearances 1

Regulation 21 CFR 870.4075

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MPE Class 2

Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker

Clearances 1

Regulation 21 CFR 870.5550

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NKU Class 2

Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed

Clearances 1

Regulation 21 CFR 870.1650

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NLI Class 2

Catheter, Angiography, Reprocessed

Clearances 1

Regulation 21 CFR 870.1200

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NMK Class 2

Trocar, Reprocessed

Clearances 1

Regulation 21 CFR 870.1390

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NPG Class 2

Catheter, Infusion, Syringe

Clearances 1

Regulation 21 CFR 870.1210

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NPP Class 2

Reprocessed Blood Pressure Cuff

Clearances 1

Regulation 21 CFR 870.1120

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NSA Class 3

Over-The-Counter Automated External Defibrillator

Clearances 1

Regulation 21 CFR 870.5310

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OBI Class 2

Catheter, Pressure Monitoring, Cardiac

Clearances 1

Regulation 21 CFR 870.1200

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OFC Class 2

Catheter Introducer Kit

Clearances 1

Regulation 21 CFR 870.1340

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OJQ Class 2

Cardiac Allograft Gene Expression Profiling Test System

Clearances 1

Regulation 21 CFR 862.1163

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OMH Class 2

Pericardial Patch To Facilitate Revision Surgeries

Clearances 1

Regulation 21 CFR 870.3470

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OMV Class 2

Ultrasonic Body Composition Analyzer

Clearances 1

Regulation 21 CFR 870.2770

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PFA Class 2

Non-Invasive Central Venous Manometer

Clearances 1

Regulation 21 CFR 870.1140

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PNS Class 2

Short-Term Intravascular Filter Catheter

Clearances 1

Regulation 21 CFR 870.3375

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PPS Class 2

Sleeve, Head And Neck, Compressible

Clearances 1

Regulation 21 CFR 870.5800

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QBE Class 2

Cranial Sound Monitor

Clearances 1

Regulation 21 CFR 870.1875

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QEM Class 2

Cerebral Oximeter

Clearances 1

Regulation 21 CFR 870.2700

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QFJ Class 2

Intravascular Bleed Monitor

Clearances 1

Regulation 21 CFR 870.1345

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QJH Class 2

Reverse Central Venous Recanalization System

Clearances 1

Regulation 21 CFR 870.1342

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QMS Class 2

Adjunctive Open Loop Fluid Therapy Recommender

Clearances 1

Regulation 21 CFR 870.5600

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QOK Class 2

Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate

Clearances 1

Regulation 21 CFR 870.2786

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QTF Class 2

Reprocessed Atherectomy Catheter

Clearances 1

Regulation 21 CFR 870.4875

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QVQ Class 2

Extravascular Support For An Arteriovenous Fistula For Vascular Access

Clearances 1

Regulation 21 CFR 870.4600

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QWF Class 2

Tubing, Long Term Support Greater Than 6 Hours

Clearances 1

Regulation 21 CFR 870.4100

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QXO Class 2

Cardiovascular Machine Learning-Based Notification Software

Clearances 1

Regulation 21 CFR 870.2380

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QXU Class 2

Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation

Clearances 1

Regulation 21 CFR 870.5710

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QXX Class 2

Coronary Artery Disease Machine Learning-Based Notification Software

Clearances 1

Regulation 21 CFR 870.2380

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QXZ Class 2

Adjunctive Epicardial Vascular Physiologic Status Indicator

Clearances 1

Regulation 21 CFR 870.2200

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QYU Class 2

Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use

Clearances 1

Regulation 21 CFR 870.2705

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QYW Class 2

Hospital Cardiac Telemetry

Clearances 1

Regulation 21 CFR 870.1025

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SAR Class 2

Adjunctive Hemodynamic Indicator With Decision Point For Military Use

Clearances 1

Regulation 21 CFR 870.2220

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SDY Class 2

Loss Of Pulse Notification Software

Clearances 1

Regulation 21 CFR 870.2790

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SFR Class 2

Hypertension Machine Learning-Based Notification Software

Clearances 1

Regulation 21 CFR 870.2380

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SGO Class 2

Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Clearances 1

Regulation 21 CFR 870.1254

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SHP Class 2

Cardiac Amyloidosis Machine Learning-Based Notification Software

Clearances 1

Regulation 21 CFR 870.2380

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DQG Class 3

Microsphere, Trace

Clearances 0

Regulation 21 CFR 870.1360

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DQP Class 3

Kit, Balloon Repair, Catheter

Clearances 0

Regulation 21 CFR 870.1350

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DRP Class 2

Tourniquet, Automatic Rotating

Clearances 0

Regulation 21 CFR 870.5925

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DRZ Class 2

Oscillometer

Clearances 0

Regulation 21 CFR 870.2675

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DSR Class 3

Stimulator, Carotid Sinus Nerve

Clearances 0

Regulation 21 CFR 870.3850

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DSW Class 1

Bag, Polymeric Mesh, Pacemaker

Clearances 0

Regulation 21 CFR 870.3650

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DSZ Class 3

Pacemaker Battery

Clearances 0

Regulation 21 CFR 870.3610

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DYE Class 3

Replacement Heart-Valve

Clearances 0

Regulation 21 CFR 870.3925

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JON Class 2

Transducer, Apex Cardiographic

Clearances 0

Regulation 21 CFR 870.2840

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JOO Class 2

Transducer, Heart Sound

Clearances 0

Regulation 21 CFR 870.2860

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JOR Class 3

Generator, Pulsatile Flow, Cardiopulmonary Bypass

Clearances 0

Regulation 21 CFR 870.4320

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KRF Class 1

Charger, Pacemaker

Clearances 0

Regulation 21 CFR 870.3670

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MLN Class 2

Electrode, Electrocardiograph, Multi-Function

Clearances 0

Regulation 21 CFR 870.2360

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MPC Class 3

Atrial Defibrillator

Clearances 0

Regulation 21 CFR 870.5300

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MZY Class 2

Graft, Vascular, Stainless Steel Tunneler

Clearances 0

Regulation 21 CFR 870.3450

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NKO Class 3

System, Balloon, Intra-Aortic And Control, Reprocessed

Clearances 0

Regulation 21 CFR 870.3535

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NKP Class 2

Injector, Contrast Medium, Automatic, Reprocessed

Clearances 0

Regulation 21 CFR 870.1650

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NKQ Class 2

Guidewire, Catheter, Reprocessed

Clearances 0

Regulation 21 CFR 870.1330

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NKR Class 2

System, Catheter Control, Reprocessed

Clearances 0

Regulation 21 CFR 870.1290

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NKS Class 2

Catheter, Steerable, Reprocessed

Clearances 0

Regulation 21 CFR 870.1280

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NKT Class 2

Injector And Syringe, Angiographic, Reprocessed

Clearances 0

Regulation 21 CFR 870.1650

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NKW Class 2

Actuator, Syringe, For Injector, Reprocessed

Clearances 0

Regulation 21 CFR 870.1670

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NLJ Class 2

Stripper, Vein, External, Reprocessed

Clearances 0

Regulation 21 CFR 870.4885

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NMB Class 2

Catheter, Oximeter, Fiber Optic, Reprocessed

Clearances 0

Regulation 21 CFR 870.1230

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NMM Class 2

Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed

Clearances 0

Regulation 21 CFR 870.1250

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OCH Class 2

Oximeter, Infrared, Sporting, Aviation

Clearances 0

Regulation 21 CFR 870.2700

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OEQ Class 2

Angiography/Angioplasty Kit

Clearances 0

Regulation 21 CFR 870.1650

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OER Class 2

Angioscopic Valvulotome Kit

Clearances 0

Regulation 21 CFR 870.1650

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OES Class 2

Cardiac Catheterization Kit

Clearances 0

Regulation 21 CFR 870.1200

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OET Class 2

Cardioplegia Solution Administration Kit

Clearances 0

Regulation 21 CFR 870.4240

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OEU Class 2

Cardiopulmonary Bypass Catheter Kit

Clearances 0

Regulation 21 CFR 870.4210

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OEX Class 2

Cardiovascular Catheter Sheath Introducer Kit

Clearances 0

Regulation 21 CFR 870.1340

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OEZ Class 2

Cardiovascular Procedure Kit

Clearances 0

Regulation 21 CFR 870.1200

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OFA Class 1

Cardiovascular Surgical Instruments Tray

Clearances 0

Regulation 21 CFR 870.4500

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OFB Class 2

Catheter Guide Wire Kit

Clearances 0

Regulation 21 CFR 870.1330

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OFD Class 2

Catheter Introducer Kit

Clearances 0

Regulation 21 CFR 870.1340

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OFE Class 2

Central Venous Blood Pressure Kit

Clearances 0

Regulation 21 CFR 870.1140

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OFF Class 2

Central Venous Catheter Tray

Clearances 0

Regulation 21 CFR 870.1140

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OFG Class 2

Ct Biopsy Tray

Clearances 0

Regulation 21 CFR 870.4075

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OFH Class 2

Digital Angiography Tray

Clearances 0

Regulation 21 CFR 870.1650

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OFI Class 2

Laser Blood Flow Kit

Clearances 0

Regulation 21 CFR 870.2120

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OFJ Class 2

Lead Introducer Kit

Clearances 0

Regulation 21 CFR 870.1340

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OFK Class 2

Percutaneous Atrial Catheter Kit

Clearances 0

Regulation 21 CFR 870.1250

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OFL Class 2

Percutaneous Sheath Introducer Kit

Clearances 0

Regulation 21 CFR 870.1340

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OFM Class 2

Phlebotomy Blood Collection Kit

Clearances 0

Regulation 21 CFR 870.2750

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OFN Class 2

Winged Intravenous Catheterization Kit

Clearances 0

Regulation 21 CFR 870.1200

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OKR Class 3

Ventricular Bypass (Assist) Device

Clearances 0

Regulation 21 CFR 870.3545

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ORD Class 2

Optical Coherence Tomography, Intravascular Catheter

Clearances 0

Regulation 21 CFR 870.1200

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OVJ Class 2

Pulse Generator, External Pacemaker, Dual Chamber

Clearances 0

Regulation 21 CFR 870.3600

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PAL Class f

Pulmonic Replacement Heart Valve

Clearances 0

Regulation 21 CFR 870.3925

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PCK Class f

Pediatric Ventricular Assist Device

Clearances 0

Regulation 21 CFR 870.3545

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PFY Class 2

Low Patient Acuity Monitoring System

Clearances 0

Regulation 21 CFR 870.2300

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PGJ Class 2

Oximeter, Wellness

Clearances 0

Regulation 21 CFR 870.2700

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PMJ Class 2

Cpr Aid Feedback Device (No Software)

Clearances 0

Regulation 21 CFR 870.5210

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PNJ Class 3

Leadless Pacemaker

Clearances 0

Regulation 21 CFR 870.3610

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PNQ Class 2

Apical Closure Device

Clearances 0

Regulation 21 CFR 870.4510

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PTL Class 2

Wire, Guide, Catheter, Exempt

Clearances 0

Regulation 21 CFR 870.1330

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PTM Class 2

Syringe, Balloon Inflation, Exempt

Clearances 0

Regulation 21 CFR 870.1650

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PTN Class 2

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

Clearances 0

Regulation 21 CFR 870.4400

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PUH Class 2

Analyzer, Body Composition, Exempt

Clearances 0

Regulation 21 CFR 870.2770

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PYX Class 3

Temporary Non-Roller Type Right Heart Support Blood Pump

Clearances 0

Regulation 21 CFR 870.4360

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QAB Class 2

Pacing System Analyzer

Clearances 0

Regulation 21 CFR 870.3605

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QMW Class 2

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

Clearances 0

Regulation 21 CFR 870.1420

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QOH Class 2

Extracorporeal System For Carbon Dioxide Removal

Clearances 0

Regulation 21 CFR 870.4150

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QRJ Class 2

Laser-Powered Inferior Vena Cava Filter Retrieval Catheter

Clearances 0

Regulation 21 CFR 870.5125

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QWA Class 1

Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Clearances 0

Regulation 21 CFR 870.3955

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QXV Class 2

Temperature Regulation Device For Esophageal Protection During Cardiac Ablation

Clearances 0

Regulation 21 CFR 870.5720

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QXY Class 2

Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Clearances 0

Regulation 21 CFR 870.1135

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QYF Class 2

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Clearances 0

Regulation 21 CFR 870.1130

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QZU Class 2

Temporary Embolization Assist Device, Peripheral

Clearances 0

Regulation 21 CFR 870.3325

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SBK Class 2

Artificial Chordae Tendineae Surgical Replacement System

Clearances 0

Regulation 21 CFR 870.3490

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SCZ Class 2

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Clearances 0

Regulation 21 CFR 870.1254

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SEU Class 2

Peripheral Temporary And Retrievable Stent System

Clearances 0

Regulation 21 CFR 870.5110

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SHR Class 2

Device For Open Surgical Explant Of Endovascular Prostheses

Clearances 0

Regulation 21 CFR 870.4520

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SIF Class 2

Software Device System For Estimation Of Cardiac Pressures

Clearances 0

Regulation 21 CFR 870.1150

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SII Class 2

Aortic Stenosis Machine Learning-Based Notification Software

Clearances 0

Regulation 21 CFR 870.2380

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SIJ Class 2

Valvular Regurgitation Machine Learning-Based Notification Software

Clearances 0

Regulation 21 CFR 870.2380

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SIK Class 2

Cardiac Hypertrophy Machine Learning-Based Notification Software

Clearances 0

Regulation 21 CFR 870.2380

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SIU Class 2

Predictive Indicator For Long-Term Cardiovascular Outcomes

Clearances 0

Regulation 21 CFR 870.2215

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