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 1998-12-22

RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D

Applicant Cardiac Pathways Corp.

K number K983653

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DRF 1998-10-29

ELECTRODE SWITCHBOX, MODEL 11-081002

Applicant Cardima, Inc.

K number K982835

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DRF 1998-08-10

CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210

Applicant Cordis Webster, Inc.

K number K982415

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DRF 1998-08-05

STABLEMAPR STEERABLE INTRACARDIAC CATHETERS

Applicant Medtronic Cardiorhythm

K number K981642

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DRF 1998-07-25

MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

Applicant Irvine Biomedical, Inc.

K number K982232

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DRF 1998-07-01

CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER

Applicant Cardima, Inc.

K number K971975

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DRF 1998-05-28

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.

Applicant Cordis Webster, Inc.

K number K980961

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DRF 1998-04-20

ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.

Applicant J-Lloyd Medical, Inc.

K number K973639

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DRF 1998-04-20

HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

Applicant J-Lloyd Medical, Inc.

K number K971504

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DRF 1997-11-04

PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)

Applicant Cardima, Inc.

K number K970853

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DRF 1997-10-23

VIKING DIAGNOSTIC ELECTRODE CATHETER

Applicant C.R. Bard, Inc.

K number K971265

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DRF 1997-08-11

ARRHYTHMIA MAPPING SYSTEM (8100/8300)

Applicant Cardiac Pathways Corp.

K number K965066

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DRF 1997-06-25

HARMAC QUADPOLAR MAPPING PACING CATHETER

Applicant Harmac Medical Products, Inc.

K number K963074

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DRF 1997-04-11

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

Applicant Irvine Biomedical, Inc.

K number K961924

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DRF 1997-01-29

GYRO TIP EP CATHETER

Applicant Cardiac Assist Devices, Inc.

K number K955847

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DRF 1997-01-29

PATHFINDER

Applicant Cardima, Inc.

K number K955802

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DRF 1997-01-23

PERFORMR SERIES EP DIAGNOSTIC CATHETERS

Applicant Medtronic Cardiorhythm

K number K964272

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DRF 1996-10-22

ELECTRODE RECORDING CATHETER

Applicant Boston Scientific Corp

K number K954651

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DRF 1996-09-18

CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

Applicant Cordis Webster, Inc.

K number K953663

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DRF 1996-09-17

RHYDER DIAGNOSTIC CATHETER

Applicant Fidus Medical Technology Corp.

K number K962307

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DRF 1996-04-15

NOGA

Applicant Biosense, Ltd.

K number K960542

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DRF 1996-04-15

PLATINUM SERIES EP DIAGNOSTIC CATHETERS

Applicant Medtronic Cardiorhythm

K number K953185

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DRF 1996-03-25

CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER

Applicant Cordis Webster, Inc.

K number K955817

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DRF 1996-03-11

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Applicant Boston Scientific Corp

K number K953750

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DRF 1995-12-21

CORDIS WESTER STAR CATHETER

Applicant Cordis Webster, Inc.

K number K954390

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DRF 1995-11-30

DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM

Applicant Arrow Intl., Inc.

K number K953651

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DRF 1995-11-22

CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

Applicant Cordis Webster, Inc.

K number K953768

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DRF 1995-08-08

ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS

Applicant Arrow Intl., Inc.

K number K945229

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DRF 1995-07-18

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER

Applicant Irvine Biomedical, Inc.

K number K946333

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DRF 1995-05-31

HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER

Applicant Heart Rhythm Technologies, Inc.

K number K932388

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DRF 1995-05-10

MARINR SERIES EP DIAGNOSTI CATHETERS

Applicant Medtronic Cardiorhythm

K number K951347

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DRF 1995-05-04

LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS

Applicant Boston Scientific Corp

K number K951744

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DRF 1995-05-04

ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER

Applicant Echocath, Inc.

K number K933417

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DRF 1995-04-19

TIP DEFLECTOR (GENESIS)

Applicant Electro-Catheter Corp.

K number K943257

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DRF 1995-04-19

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION

Applicant Electro-Catheter Corp.

K number K933451

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DRF 1995-04-19

CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION

Applicant Electro-Catheter Corp.

K number K933450

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DRF 1994-12-27

DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

Applicant Daig Corp.

K number K942379

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DRF 1994-08-02

DIAGNOSTIC I CATHETER

Applicant Ep Technologies, Inc.

K number K940167

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DRF 1994-07-27

DIAGNOSTIC II CATHETER

Applicant Ep Technologies, Inc.

K number K940168

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DRF 1994-06-06

MARINR SERIES EP DIAGNOSTIC CATHETERS

Applicant Medtronic Cardiorhythm

K number K931794

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DRF 1993-12-16

STEEROCATH II

Applicant Ep Technologies, Inc.

K number K924109

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DRF 1993-12-16

TRACFINDER II

Applicant Ep Technologies, Inc.

K number K924108

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DRF 1993-12-06

ENDOCATH ELECTROPHYSIOLOGY CATHETER

Applicant Endo-Therapeutics, Inc.

K number K926549

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DRF 1993-09-03

EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC

Applicant Boston Scientific Corp

K number K924163

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DRF 1993-02-10

VOYAGR SERIES DIAGNOSTIC EP CATHETERS

Applicant Cardiorhythm

K number K923916

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DRF 1993-02-10

TORQR SERIES DIAGNOSTIC EP CATHETERS

Applicant Cardiorhythm

K number K923915

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DRF 1992-06-18

ARROW QUADPOLAR MAPPING/PACING CATHETER

Applicant Arrow Intl., Inc.

K number K911065

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DRF 1992-03-09

VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER

Applicant Arrhythmia Technologies, Inc.

K number K915640

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DRF 1992-03-09

DIAGNOSTIC EP CATHETER

Applicant Arrhythmia Technologies, Inc.

K number K915563

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DRF 1992-03-04

DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN

Applicant Daig Corp.

K number K914278

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DRF 1992-02-07

PEDIATRIC MULTI-FUNCTION ELECTRODES

Applicant Zmi Corp.

K number K915159

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DRF 1991-11-22

MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES

Applicant Medtronic Vascular

K number K914460

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DRF 1991-10-25

TORQUE TUBE STEEROCATH(TM)

Applicant Ep Technologies, Inc.

K number K913375

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DRF 1991-10-09

PEI PLAQUE ELECTRODE ARRAY

Applicant Prucka Engineering, Inc.

K number K904747

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DRF 1991-05-07

BARD(R) ENDOCARDIAL BALLOON ARRAY

Applicant C.R. Bard, Inc.

K number K911140

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DRF 1991-03-29

ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH

Applicant Arzco Medical Electronics, Inc.

K number K905831

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DRF 1991-01-18

ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

Applicant Arzco Medical Electronics, Inc.

K number K903136

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DRF 1990-10-12

FRANZ(TM) STEERABLE COMBINATION CATHETER

Applicant Ep Technologies, Inc.

K number K903880

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DRF 1990-07-06

MODIFIED EPICARDIAL ARRAY

Applicant C.R. Bard, Inc.

K number K902228

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DRF 1990-05-07

STEEROCATH(TM)

Applicant Ep Technologies, Inc.

K number K900765

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DRF 1990-03-14

QUATTRO CATHETER

Applicant Ep Technologies, Inc.

K number K900452

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DRF 1989-12-13

PE INTERCARDIAC MAPPING SYSTEM (ICMS)

Applicant Prucka Engineering, Inc.

K number K895916

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DRF 1989-09-18

DAIG ELECTROPHYSIOLOGY CATHETER

Applicant Daig Corp.

K number K894500

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DRF 1989-07-14

BARD PLAQUE ELECTRODE ARRAY

Applicant Bard Electrophysiology

K number K893611

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DRF 1989-06-12

FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED

Applicant Ep Technologies, Inc.

K number K892207

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DRF 1989-06-05

BARD(R) TIP DEFLECTING ELECTRODE CATHETER

Applicant C.R. Bard, Inc.

K number K891908

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DRF 1988-10-04

ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER

Applicant C.R. Bard, Inc.

K number K881966

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DRF 1988-07-18

FRANZ CATHETER

Applicant Ep Technologies, Inc.

K number K881853

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DRF 1988-01-07

BARD DESAI CATHETER ELECTRODE

Applicant C.R. Bard, Inc.

K number K873995

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DRF 1987-12-29

BARD OCTAPOLAR ELECTRODE CATHETER

Applicant C.R. Bard, Inc.

K number K874208

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DRF 1987-10-09

BARD EPICARDIAL ELECTRODE ARRAY

Applicant C.R. Bard, Inc.

K number K872231

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DRF 1985-01-02

ELECATH GALLAGHER MAPPING CATHETER

Applicant Electro-Catheter Corp.

K number K844805

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DRF 1984-05-09

SWITCHING UNIT ELECTRODE CATHETER

Applicant Webster Laboratories, Inc.

K number K834602

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DRF 1983-06-30

MODEL TP THERMISTOR PROBE

Applicant Scimed Life Systems, Inc.

K number K831528

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DRF 1983-01-14

SWITCHING UNIT ELECTRODE CATHETERS

Applicant Webster Laboratories, Inc.

K number K823361

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DRF 1982-11-30

MIKRO-TIP CATHETER PRESSURE TRANSDUCER

Applicant Millar Instruments, Inc.

K number K823434

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DRF 1981-11-16

MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.

Applicant Millar Instruments, Inc.

K number K812944

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DRF 1980-11-19

MAPPING PROBE MODEL #6540

Applicant Cardiac Pacemakers, Inc.

K number K802058

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DRF 1977-04-27

PROBE, TEMPERATURE, SYSTEM, SARNS

Applicant 3M Health Care, Sarns

K number K770709

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DRF 1977-03-30

CITADEL REFERENCE ELECTRODE

Applicant Sherwood Medical Industries

K number K770477

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DRF 1977-02-28

TEMP. PROBE, & ELECTRONIC THERMOMETER

Applicant Electro-Catheter Corp.

K number K770341

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