Catheter, Intravascular, Diagnostic

FDA product code DQO · 488 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1200
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-23 – 2026-06-26

DQO 1991-10-23

HEPARIN COATED THERMODILUTION CATH & ACCESSORIES

Applicant Sunscope Intl., Inc.

K number K911710

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DQO 1991-10-18

CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH

Applicant Cordis Corp.

K number K914007

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DQO 1991-09-06

ACS RX SUPPORT CATHETER

Applicant Advanced Cardiovascular Systems, Inc.

K number K911957

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DQO 1991-08-30

SCIMED 7 FR. & 8 FR.

Applicant Scimed Life Systems, Inc.

K number K913364

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DQO 1991-07-30

POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF

Applicant The R Group

K number K912076

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DQO 1991-07-09

TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES

Applicant Target Therapeutics

K number K911605

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DQO 1991-07-05

ZEPHYR INFUSION CATHETER

Applicant Target Therapeutics

K number K911560

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DQO 1991-06-28

CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER

Applicant Cordis Corp.

K number K911703

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DQO 1991-06-10

BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH

Applicant Baxter Healthcare Corp

K number K911367

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DQO 1991-05-29

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

Applicant Scimed

K number K910987

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DQO 1991-04-24

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)

Applicant Baxter Healthcare Corp

K number K910204

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DQO 1991-04-22

PRESSURE MONITORING EXTENSION LINE

Applicant Professional Medical Services

K number K910378

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DQO 1991-04-18

SCHNEIDER MAGNARAIL PROBING CATHETER

Applicant Schneider Intl., Ltd.

K number K910259

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DQO 1991-04-12

CVIS INSIGHT IMAGING CATHETER

Applicant Cardiovascular Imaging Systems, Inc.

K number K904618

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DQO 1991-04-01

BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS

Applicant Baxter Healthcare Corp

K number K910208

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DQO 1991-03-25

DIAGNOSTIC INTRASCULAR CATHETER

Applicant Applied Vascular Devices, Inc.

K number K903848

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DQO 1991-03-18

ACS ANGIOSCOPIC CATHETER

Applicant Advanced Cardiovascular Systems, Inc.

K number K905715

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DQO 1991-02-21

CVIS INSIGHT IMAGING CATHETER

Applicant Cardiovascular Imaging Systems, Inc.

K number K905625

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DQO 1991-02-11

SCIMD 7 FR. TRIGUIDE GUIDING CATHETER

Applicant Scimed Life Systems, Inc.

K number K905499

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DQO 1991-02-01

USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER

Applicant C.R. Bard, Inc.

K number K905727

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DQO 1991-02-01

DIAVENTIONAL CATHETER

Applicant Cordis Corp.

K number K905297

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DQO 1991-02-01

TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000

Applicant Lifestream Int'L, Inc.

K number K904491

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DQO 1991-01-16

LAB-SITE SAFETY NEEDLE

Applicant Telos Medical Corp.

K number K905018

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DQO 1991-01-15

LAB-SITE

Applicant Telos Medical Corp.

K number K905017

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DQO 1990-12-17

PSG HEMOSTATIC CONTROL VALVE

Applicant Peripheral Systems Group

K number K904959

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DQO 1990-12-17

MEWISSEN CATHETER

Applicant Boston Scientific Corp

K number K904788

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DQO 1990-12-17

HOLLOW LUMEN NEEDLE, PART NUMBER: MX920

Applicant Medex, Inc.

K number K903199

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DQO 1990-12-17

WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER

Applicant Wilson Biomedical, Inc.

K number K892671

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DQO 1990-11-05

ARTERIAL BLOOD SAMPLING KIT

Applicant Medex, Inc.

K number K902771

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DQO 1990-10-03

RSI FEMORAL GUIDING CATHETER

Applicant Retroperfusion Systems, Inc.

K number K902943

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DQO 1990-09-28

SOFTOUCH GUIDING CATHETER

Applicant Mallinckrodt Medical

K number K902953

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DQO 1990-07-17

MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER

Applicant Novoste Corp.

K number K900460

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DQO 1990-07-06

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE

Applicant Cardiovascular Imaging Systems, Inc.

K number K901691

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DQO 1990-06-28

SCIMED CORONARY GUIDING CATHETER

Applicant Scimed Life Systems, Inc.

K number K895437

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DQO 1990-04-23

USCI 7F LARGE LUMEN GUIDING CATHETER

Applicant C.R. Bard, Inc.

K number K895180

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DQO 1990-04-19

BALLOON THERMODILUTION CATHETERS

Applicant Worldwide Medical

K number K894401

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DQO 1990-04-06

SONICATH(TM) 5 F

Applicant Boston Scientific Corp

K number K895542

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DQO 1990-03-28

CORDIS SHUTTLE CATHETER

Applicant Cordis Corp.

K number K896308

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DQO 1990-03-16

MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH

Applicant Cathlab Corp.

K number K897051

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DQO 1990-02-28

SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.

Applicant Schneider Intl., Ltd.

K number K896741

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DQO 1990-01-24

MODIFIED ANGIOGRAPHIC CATHETER

Applicant Novoste Corp.

K number K896690

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DQO 1990-01-19

GUIDING CATHETER

Applicant Peripheral Systems Group

K number K895146

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DQO 1989-12-28

MULTILUMEN CENTRAL VENOUS CATHETER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K885221

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DQO 1989-12-20

BIOCHEM 3100 OXIMETER

Applicant Biochem International, Inc.

K number K893877

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DQO 1989-11-27

SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F

Applicant Baxter Healthcare Corp

K number K894168

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DQO 1989-11-06

ARROW HANDS-OFF THERMO-PACE

Applicant Arrow Intl., Inc.

K number K895268

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DQO 1989-10-12

HEMO-ALERT

Applicant Koregon Enterprise, Inc.

K number K893830

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DQO 1989-08-03

INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING

Applicant Boston Scientific Corp

K number K891580

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DQO 1989-05-19

E-Z-FLOW ANGIOGRAPHY CATHETERS

Applicant E-Z-Em, Inc.

K number K890206

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DQO 1989-05-15

A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL

Applicant Mallinckroot, Inc.

K number K885348

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DQO 1989-04-24

USCI 7F GUIDE CATHETER

Applicant C.R. Bard, Inc.

K number K890420

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DQO 1989-04-21

IMAGER FLUSH CATHETERS

Applicant Medi-Tech, Inc.

K number K884354

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DQO 1989-01-26

ANGIOSCOPE FOR PULMONARY ARTERY USE

Applicant Washington Regulatory Services

K number K882658

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DQO 1989-01-18

USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER

Applicant C.R. Bard, Inc.

K number K884502

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DQO 1989-01-12

CATH LAB MONITORING CATHETER

Applicant C.R. Bard, Inc.

K number K884065

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DQO 1988-11-18

MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER

Applicant Millar Instruments, Inc.

K number K883651

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DQO 1988-10-06

USCI SOFT-TIP ANGIOGRAPHIC CATHETER

Applicant C.R. Bard, Inc.

K number K883051

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DQO 1988-09-16

PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE

Applicant Procedure Packs, Inc.

K number K882655

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DQO 1988-08-09

NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS

Applicant Novoste Corp.

K number K875127

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DQO 1988-07-28

SLIP-COAT(TM) CATHETERS

Applicant Cook, Inc.

K number K882796

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DQO 1988-05-25

HEPARIN COATED LUMINAL PACING CATHETER

Applicant Spectramed, Inc.

K number K875337

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DQO 1988-05-02

FIBEROPTIC CATHETER

Applicant Optimed Technologies, Inc.

K number K880661

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DQO 1988-02-18

MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER

Applicant Schneider-Shilley (Usa)

K number K875326

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DQO 1988-02-18

MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK

Applicant Schneider-Shilley (Usa)

K number K875325

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DQO 1988-02-05

TARGET THERAPEUTICS STERILE PRODUCTS

Applicant Target Therapeutics

K number K874815

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DQO 1988-01-29

ANGIO WASTE FLUIDS DUMP BAG

Applicant Procedure Products, Inc.

K number K874037

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DQO 1987-12-03

MICRO-GUIDE

Applicant Catheter Research C/O Burditt, Bowles & Radzius

K number K870700

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DQO 1987-11-27

USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER

Applicant C.R. Bard, Inc.

K number K873438

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DQO 1987-09-15

GUIDING CATHETER

Applicant Mallinckrodt Critical Care

K number K873004

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DQO 1987-08-12

DOUBLE LUMEN CATHETER

Applicant Cordis Corp.

K number K872248

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DQO 1987-06-16

GUIDING CATHETERS 9F JL4

Applicant Devices For Vascular Intervention, Inc.

K number K871021

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DQO 1987-05-11

IVR-SP CUSTOM ANGIOGRAPHY TRAY

Applicant North Coast Medi-Tek

K number K870419

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DQO 1987-02-20

NUMED BALLOON WEDGE PRESSURE CATHETER

Applicant NuMED, Inc.

K number K864943

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DQO 1987-02-19

NUMED BALLOON ANGIOGRAPHIC CATHETERS

Applicant NuMED, Inc.

K number K864940

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DQO 1987-01-06

ANGIOTOPO CATHETER

Applicant Houston Biomedical, Inc.

K number K861241

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DQO 1986-11-10

CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON

Applicant Cortronic Corp.

K number K852547

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DQO 1986-11-03

CORDIS CONTRAST INJECTION LINES

Applicant Cordis Corp.

K number K864141

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DQO 1986-10-10

TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER

Applicant Terumo Medical Corp.

K number K863137

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DQO 1986-09-29

CORDIPAK CARDIAC CATHETERIZATION PACK

Applicant Angi-Pak Corp.

K number K863337

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DQO 1986-09-11

MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER

Applicant Medtronic Vascular

K number K862673

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DQO 1986-08-29

SCHNEIDER-SHILEY FLUSHING CATHETER

Applicant Shiley, Inc.

K number K862466

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DQO 1986-08-28

SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR

Applicant Shiley, Inc.

K number K862464

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DQO 1986-08-25

MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS

Applicant Cordis Corp.

K number K862244

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DQO 1986-08-11

SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK

Applicant Shiley, Inc.

K number K862465

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DQO 1986-08-08

POLY-TECH ANGIOGRAPHY CATHETER

Applicant Poly-Tech Medical Device Research & Development

K number K862030

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DQO 1986-07-17

ANGIOFLOW

Applicant Angiomed U.S., Inc.

K number K854910

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DQO 1986-07-10

ACS CORONARY GUIDING CATHETER

Applicant Advanced Cardiovascular Systems, Inc.

K number K861236

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DQO 1986-07-02

DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS

Applicant Medical Components, Inc.

K number K860867

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DQO 1986-06-27

STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH

Applicant Cordis Corp.

K number K862006

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DQO 1986-05-15

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)

Applicant Mallinckrodt Critical Care

K number K861483

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DQO 1986-05-08

PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337

Applicant Gould, Inc.

K number K860805

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DQO 1986-04-23

MEADOX SURGIMED GUIDE CATHETER

Applicant Meadox Surgimed, Inc.

K number K860429

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DQO 1986-03-31

ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP

Applicant Advanced Cardiovascular Systems, Inc.

K number K860580

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DQO 1986-02-26

MODIFIED CORDIS PTCA GUIDING CATHETERS

Applicant Cordis Corp.

K number K854576

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DQO 1986-02-18

CIRIBART GYUDUBG CATGETER

Applicant Mansfield Scientific, Inc.

K number K855103

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DQO 1986-01-16

ANGIOGRAPHY CATHETERS

Applicant Micor, Inc.

K number K854018

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DQO 1986-01-15

DIAGNOSTIC INTRAVASCULAR CATHETERS

Applicant Mallinckrodt Critical Care

K number K853182

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DQO 1985-11-06

LAP-CATH

Applicant Research Medical, Inc.

K number K852197

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DQO 1985-11-01

FAP-CATH

Applicant Research Medical, Inc.

K number K852456

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DQO 1985-10-11

ANGIOMEDICS SOFTIP CATHETER

Applicant Angiomedics, Inc.

K number K852872

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