Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA product code DRF · 181 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1220
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-02-28 – 2026-01-08

DRF 2026-01-08

Vision-MR™ Diagnostic Catheter

Applicant Imricor Medical Systems, Inc.

K number K252794

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DRF 2025-07-23

MAGiC Sweep™ EP Mapping Catheter

Applicant Stereotaxis, Inc.

K number K250590

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DRF 2025-06-27

VIKING™ Fixed Curve Diagnostic Catheter

Applicant Boston Scientific Corporation

K number K250310

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DRF 2024-11-01

EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K number K240366

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DRF 2024-09-06

Nordica PV Cryo Mapping Catheter

Applicant Synaptic Medical Corporation

K number K233900

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DRF 2023-12-02

Cosine-10TM Diagnostic Catheter

Applicant Medtronic, Inc.

K number K233397

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DRF 2023-10-27

Polaris X™ Unidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K number K233207

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DRF 2023-09-29

BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K number K232651

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DRF 2023-04-25

Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable

Applicant Boston Scientific

K number K230503

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DRF 2022-12-30

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

Applicant Shanghai Microport EP Medtech Co., Ltd.

K number K210313

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DRF 2022-06-10

IntellaMap Orion High Resolution Mapping Catheter

Applicant Boston Scientific Corporation

K number K220796

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DRF 2022-02-14

RithmID-SD Steerable Diagnostic Electrophysiology Catheter

Applicant Synaptic Medical Corporation

K number K203793

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DRF 2022-02-10

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

Applicant CathRx, Ltd.

K number K211327

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DRF 2022-01-26

LASSOSTAR NAV Circular Mapping Catheter

Applicant Biosense Webster, Inc.

K number K211219

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DRF 2021-10-15

ViaCath, AcQRate Dx Steerable Catheter

Applicant Biotronick, Inc.

K number K212593

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DRF 2021-09-14

Polaris X Unidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K number K211494

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DRF 2021-09-10

Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter

Applicant Boston Scientific Corporation

K number K211375

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DRF 2021-09-02

MultiCath, AcQRate Dx Fixed Curve Catheter

Applicant Biotronik, Inc.

K number K201445

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DRF 2021-03-05

Reprocessed Inquiry Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K number K203261

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DRF 2020-06-30

LassoStar Circular Mapping Catheter

Applicant Biosense Webster, Inc.

K number K193632

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DRF 2019-12-11

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter

Applicant Innovative Health, LLC

K number K191880

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DRF 2019-10-25

IntellaMap Orion High Resolution Mapping Catheter

Applicant Boston Scientific Corporation

K number K192360

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DRF 2019-09-17

Advisor VL Circular Mapping Catheter, Sensor Enabled

Applicant ABBOTT MEDICAL

K number K192037

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DRF 2019-07-30

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

Applicant Medtronic

K number K190132

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DRF 2019-07-30

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

Applicant Medtronic

K number K183547

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DRF 2019-07-01

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

Applicant Innovative Health, LLC

K number K190980

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DRF 2019-06-07

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

Applicant Baylis Medical Company, Inc.

K number K183649

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DRF 2019-06-07

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable

Applicant Baylis Medical Company, Inc.

K number K183632

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DRF 2019-04-23

Reprocessed Supreme Diagnostic Electrophysiology Catheter

Applicant Innovative Health, LLC

K number K182386

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DRF 2017-10-23

Reprocessed Inquiry Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K number K171277

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DRF 2016-12-13

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D

Applicant St Jude Medical

K number K160335

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DRF 2016-12-06

Reprocessed Supreme Diagnostic Electrophysiology Catheters

Applicant Innovative Health, LLC

K number K161769

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DRF 2016-11-15

Achieve Advance Mapping Catheter

Applicant Medtronic, Inc.

K number K162892

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DRF 2016-10-18

EasyMap MAP Catheter

Applicant Medfact Engineering GmbH

K number K151139

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DRF 2016-05-06

Achieve ST Mapping Catheter, Catheter Connecting Cable

Applicant Medtronic, Inc.

K number K153139

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DRF 2016-04-11

Map-it Diagnostic Mapping Catheters

Applicant Access Point Technologies Ep, Inc.

K number K160390

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DRF 2013-08-14

LASSO NAV DUO LOOP CATHETER

Applicant Biosense Webster, Inc.

K number K130602

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DRF 2013-04-18

RHYTHMIA MAPPING CATHETER

Applicant Rhythmia Medical, Inc.

K number K122461

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DRF 2012-03-19

RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN

Applicant St Jude Medical

K number K120544

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DRF 2011-12-05

LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2

Applicant Biosense Webster, Inc.

K number K113213

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DRF 2011-05-02

WEBSTER DUO-DECAPOLAR CATHETER

Applicant Biosense Webster, Inc.

K number K101991

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DRF 2011-03-18

ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE

Applicant Medtronic Ablation Frontiers, LLC

K number K102588

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DRF 2010-10-18

LIVEWIRE ELECTOPHYSIOLOGY CATHETER

Applicant St Jude Medical

K number K102721

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DRF 2010-10-15

ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058

Applicant St Jude Medical

K number K101955

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DRF 2010-08-13

INQUIRY AFOCUSII DIAGNOSTIC CATHETER

Applicant St Jude Medical

K number K101623

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DRF 2010-06-22

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

Applicant Biosense Webster, Inc.

K number K101345

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DRF 2010-06-18

LASSO NAV CATHETER

Applicant Biosense Webster, Inc.

K number K093376

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DRF 2009-09-04

CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER

Applicant Biosense Webster, Inc.

K number K090898

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DRF 2009-06-05

RADIA STEERABLE DIAGNOSTIC CATHETER

Applicant C.R. Bard, Inc.

K number K091370

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DRF 2009-05-13

ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM

Applicant St Jude Medical

K number K081803

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DRF 2009-03-24

REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106

Applicant Biosense Webster, Inc.

K number K090120

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DRF 2009-02-03

BLAZER DX-20 DIAGNOSTIC CATHETER

Applicant Boston Scientific Corp

K number K081576

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DRF 2009-01-07

REFLEXION HD HIGH-DENSITY MAPPING CATHETER

Applicant St Jude Medical

K number K080179

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DRF 2009-01-06

VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02

Applicant Biosense Webster, Inc.

K number K081258

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DRF 2008-08-19

INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER

Applicant Irvine Biomedical, Inc.

K number K082061

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DRF 2008-04-23

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

Applicant Biosense Webster, Inc.

K number K080425

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DRF 2007-08-22

REFLEXION SPIRAL VARIABLE RADIUS CATHETER

Applicant St Jude Medical

K number K072012

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DRF 2007-01-12

PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25

Applicant Prorhythm

K number K061678

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DRF 2006-10-20

REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804

Applicant St Jude Medical

K number K062251

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DRF 2006-08-14

REFSTAR EXTERNAL REFERENCE PATCH

Applicant Biosense Webster, Inc.

K number K061468

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DRF 2006-08-14

ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S

Applicant Biosense Webster, Inc.

K number K061463

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DRF 2006-06-19

CARTO RMT EP NAVIGATION SYSTEM V8

Applicant Biosense Webster, Inc.

K number K060047

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DRF 2006-04-19

INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER

Applicant Irvine Biomedical, Inc.

K number K060757

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DRF 2006-03-21

INQUIRY AFOCUS II DIAGNOSTIC CATHETER

Applicant Irvine Biomedical, Inc.

K number K053582

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DRF 2005-09-29

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER

Applicant Biosense Webster, Inc.

K number K052083

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DRF 2005-09-29

REFSTAR RMT EXTERNAL REFERENCE PATCH

Applicant Biosense Webster, Inc.

K number K042998

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DRF 2005-06-24

CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR

Applicant Biosense Webster, Inc.

K number K050877

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DRF 2005-02-03

REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM

Applicant Ep Technologies, Inc.

K number K043257

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DRF 2004-11-04

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER

Applicant Irvine Biomedical, Inc.

K number K042775

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DRF 2004-09-23

CLIPPER DIAGNOSTIC ELECTRODE CATHETER

Applicant Bard Electrophysiology

K number K042105

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DRF 2004-04-15

EP DEFLECTABLE CATHETERS

Applicant Ep Medsystems, Inc.

K number K033963

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DRF 2004-03-26

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

Applicant Medtronic Vascular

K number K033050

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DRF 2003-10-23

ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110

Applicant C.R. Bard, Inc.

K number K030627

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DRF 2003-07-22

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER

Applicant Biosense Webster, Inc.

K number K031161

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DRF 2003-07-10

4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX

Applicant Mogul Enterprises

K number K030852

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DRF 2003-04-18

PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE

Applicant Tz Medical, Inc.

K number K021421

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DRF 2002-10-01

LIVESIRE ELECTROPHYSIOLOGY CATHETER

Applicant St Jude Medical

K number K022380

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DRF 2002-05-02

TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH

Applicant Stereotaxis, Inc.

K number K013484

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DRF 2002-03-27

GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E

Applicant Cardiac Assist Devices, Inc.

K number K012520

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DRF 2001-09-06

DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE

Applicant Catheffects, LLC

K number K011361

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DRF 2001-07-13

ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE

Applicant Zynergy Cardio Vasular (Zcv), Inc.

K number K011847

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DRF 2001-07-03

6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027

Applicant St Jude Medical

K number K011766

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DRF 2001-07-03

6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX

Applicant Mogul Enterprises

K number K011734

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DRF 2001-06-06

AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569

Applicant Irvine Biomedical, Inc.

K number K010471

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DRF 2000-12-22

RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX

Applicant St Jude Medical

K number K002976

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DRF 2000-12-07

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D

Applicant Ep Technologies, Inc.

K number K003452

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DRF 2000-08-31

BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220

Applicant Biosense Webster, Inc.

K number K002333

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DRF 2000-08-16

SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX

Applicant Mogul Enterprises

K number K993698

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DRF 2000-04-06

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000

Applicant Zcv ,Inc.

K number K991060

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DRF 2000-04-06

CORDIS 13F CATHETER SHEATH INTRODUCER

Applicant Cordis Corp.

K number K000753

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DRF 2000-03-08

CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH

Applicant Cardiac Pathways Corp.

K number K992912

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DRF 1999-12-10

LUMA-CATH STEERABLE EP CATHETERS

Applicant Irvine Biomedical, Inc.

K number K991878

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DRF 1999-11-26

CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085

Applicant Cordis Webster, Inc.

K number K992965

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DRF 1999-11-05

ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE

Applicant C.R. Bard, Inc.

K number K992373

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DRF 1999-10-15

LUMA-CATH FIXED CURVE EP CATHETERS

Applicant Irvine Biomedical, Inc.

K number K991025

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DRF 1999-10-04

CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078

Applicant Cordis Webster, Inc.

K number K991531

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DRF 1999-07-15

MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER

Applicant Ep Medsystems

K number K991001

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DRF 1999-06-03

ORTHOGONAL EP CATHETERS

Applicant Irvine Biomedical, Inc.

K number K990958

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DRF 1999-05-11

TRACER O-T-W MAPPING DEVICE

Applicant Cardima, Inc.

K number K972803

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DRF 1999-02-22

PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER

Applicant Ep Medsystems

K number K984150

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