FDA Product Code
FDA Product Code DRF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1220
510(k) Clearances — 185 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K991001 | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Ep Medsystems | 1999-07-15 | Special | PDF ↗ |
| K990958 | ORTHOGONAL EP CATHETERS | Irvine Biomedical, Inc. | 1999-06-03 | Special | PDF ↗ |
| K972803 | TRACER O-T-W MAPPING DEVICE | Cardima, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER | Ep Medsystems | 1999-02-22 | Special | PDF ↗ |
| K983653 | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D | Cardiac Pathways Corp. | 1998-12-22 | Traditional | PDF ↗ |
| K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 | Cardima, Inc. | 1998-10-29 | Abbreviated | PDF ↗ |
| K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | Cordis Webster, Inc. | 1998-08-10 | Special | PDF ↗ |
| K981642 | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS | Medtronic Cardiorhythm | 1998-08-05 | Traditional | PDF ↗ |
| K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | Irvine Biomedical, Inc. | 1998-07-25 | Special | PDF ↗ |
| K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER | Cardima, Inc. | 1998-07-01 | Traditional | PDF ↗ |
| K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. | Cordis Webster, Inc. | 1998-05-28 | Traditional | PDF ↗ |
| K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | J-Lloyd Medical, Inc. | 1998-04-20 | Traditional | PDF ↗ |
| K971504 | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER | J-Lloyd Medical, Inc. | 1998-04-20 | Traditional | PDF ↗ |
| K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) | Cardima, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K971265 | VIKING DIAGNOSTIC ELECTRODE CATHETER | C.R. Bard, Inc. | 1997-10-23 | Traditional | PDF ↗ |
| K965066 | ARRHYTHMIA MAPPING SYSTEM (8100/8300) | Cardiac Pathways Corp. | 1997-08-11 | Traditional | PDF ↗ |
| K963074 | HARMAC QUADPOLAR MAPPING PACING CATHETER | Harmac Medical Products, Inc. | 1997-06-25 | Traditional | PDF ↗ |
| K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | Irvine Biomedical, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K955802 | PATHFINDER | Cardima, Inc. | 1997-01-29 | Traditional | PDF ↗ |
| K955847 | GYRO TIP EP CATHETER | Cardiac Assist Devices, Inc. | 1997-01-29 | Traditional | PDF ↗ |
| K964272 | PERFORMR SERIES EP DIAGNOSTIC CATHETERS | Medtronic Cardiorhythm | 1997-01-23 | Traditional | PDF ↗ |
| K954651 | ELECTRODE RECORDING CATHETER | Boston Scientific Corp | 1996-10-22 | Traditional | PDF ↗ |
| K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | Cordis Webster, Inc. | 1996-09-18 | Traditional | PDF ↗ |
| K962307 | RHYDER DIAGNOSTIC CATHETER | Fidus Medical Technology Corp. | 1996-09-17 | Traditional | PDF ↗ |
| K960542 | NOGA | Biosense, Ltd. | 1996-04-15 | Traditional | PDF ↗ |
| K953185 | PLATINUM SERIES EP DIAGNOSTIC CATHETERS | Medtronic Cardiorhythm | 1996-04-15 | Traditional | PDF ↗ |
| K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | Cordis Webster, Inc. | 1996-03-25 | Traditional | PDF ↗ |
| K953750 | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | Boston Scientific Corp | 1996-03-11 | Traditional | PDF ↗ |
| K954390 | CORDIS WESTER STAR CATHETER | Cordis Webster, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K953651 | DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM | Arrow Intl., Inc. | 1995-11-30 | Traditional | PDF ↗ |
| K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | Cordis Webster, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K945229 | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS | Arrow Intl., Inc. | 1995-08-08 | Traditional | PDF ↗ |
| K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER | Irvine Biomedical, Inc. | 1995-07-18 | Traditional | PDF ↗ |
| K932388 | HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER | Heart Rhythm Technologies, Inc. | 1995-05-31 | Traditional | PDF ↗ |
| K951347 | MARINR SERIES EP DIAGNOSTI CATHETERS | Medtronic Cardiorhythm | 1995-05-10 | Traditional | PDF ↗ |
| K951744 | LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS | Boston Scientific Corp | 1995-05-04 | Traditional | PDF ↗ |
| K933417 | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER | Echocath, Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION | Electro-Catheter Corp. | 1995-04-19 | Traditional | PDF ↗ |
| K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION | Electro-Catheter Corp. | 1995-04-19 | Traditional | PDF ↗ |
| K943257 | TIP DEFLECTOR (GENESIS) | Electro-Catheter Corp. | 1995-04-19 | Traditional | PDF ↗ |
| K942379 | DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER | Daig Corp. | 1994-12-27 | Traditional | PDF ↗ |
| K940167 | DIAGNOSTIC I CATHETER | Ep Technologies, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K940168 | DIAGNOSTIC II CATHETER | Ep Technologies, Inc. | 1994-07-27 | Traditional | PDF ↗ |
| K931794 | MARINR SERIES EP DIAGNOSTIC CATHETERS | Medtronic Cardiorhythm | 1994-06-06 | Traditional | PDF ↗ |
| K924109 | STEEROCATH II | Ep Technologies, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K924108 | TRACFINDER II | Ep Technologies, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | Endo-Therapeutics, Inc. | 1993-12-06 | Traditional | PDF ↗ |
| K924163 | EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC | Boston Scientific Corp | 1993-09-03 | Traditional | PDF ↗ |
| K923915 | TORQR SERIES DIAGNOSTIC EP CATHETERS | Cardiorhythm | 1993-02-10 | Traditional | PDF ↗ |
| K923916 | VOYAGR SERIES DIAGNOSTIC EP CATHETERS | Cardiorhythm | 1993-02-10 | Traditional | PDF ↗ |
| K911065 | ARROW QUADPOLAR MAPPING/PACING CATHETER | Arrow Intl., Inc. | 1992-06-18 | Traditional | PDF ↗ |
| K915563 | DIAGNOSTIC EP CATHETER | Arrhythmia Technologies, Inc. | 1992-03-09 | Traditional | PDF ↗ |
| K915640 | VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER | Arrhythmia Technologies, Inc. | 1992-03-09 | Traditional | PDF ↗ |
| K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN | Daig Corp. | 1992-03-04 | Traditional | PDF ↗ |
| K915159 | PEDIATRIC MULTI-FUNCTION ELECTRODES | Zmi Corp. | 1992-02-07 | Traditional | PDF ↗ |
| K914460 | MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES | Medtronic Vascular | 1991-11-22 | Traditional | PDF ↗ |
| K913375 | TORQUE TUBE STEEROCATH(TM) | Ep Technologies, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K904747 | PEI PLAQUE ELECTRODE ARRAY | Prucka Engineering, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K911140 | BARD(R) ENDOCARDIAL BALLOON ARRAY | C.R. Bard, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K905831 | ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH | Arzco Medical Electronics, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K903136 | ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER | Arzco Medical Electronics, Inc. | 1991-01-18 | Traditional | PDF ↗ |
| K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER | Ep Technologies, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K902228 | MODIFIED EPICARDIAL ARRAY | C.R. Bard, Inc. | 1990-07-06 | Traditional | PDF ↗ |
| K900765 | STEEROCATH(TM) | Ep Technologies, Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K900452 | QUATTRO CATHETER | Ep Technologies, Inc. | 1990-03-14 | Traditional | PDF ↗ |
| K895916 | PE INTERCARDIAC MAPPING SYSTEM (ICMS) | Prucka Engineering, Inc. | 1989-12-13 | Traditional | PDF ↗ |
| K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | Daig Corp. | 1989-09-18 | Traditional | PDF ↗ |
| K893611 | BARD PLAQUE ELECTRODE ARRAY | Bard Electrophysiology | 1989-07-14 | Traditional | PDF ↗ |
| K892207 | FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED | Ep Technologies, Inc. | 1989-06-12 | Traditional | PDF ↗ |
| K891908 | BARD(R) TIP DEFLECTING ELECTRODE CATHETER | C.R. Bard, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K881966 | ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER | C.R. Bard, Inc. | 1988-10-04 | Traditional | PDF ↗ |
| K881853 | FRANZ CATHETER | Ep Technologies, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K873995 | BARD DESAI CATHETER ELECTRODE | C.R. Bard, Inc. | 1988-01-07 | Traditional | PDF ↗ |
| K874208 | BARD OCTAPOLAR ELECTRODE CATHETER | C.R. Bard, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K872231 | BARD EPICARDIAL ELECTRODE ARRAY | C.R. Bard, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K844805 | ELECATH GALLAGHER MAPPING CATHETER | Electro-Catheter Corp. | 1985-01-02 | Traditional | PDF ↗ |
| K834602 | SWITCHING UNIT ELECTRODE CATHETER | Webster Laboratories, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K831528 | MODEL TP THERMISTOR PROBE | Scimed Life Systems, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K823361 | SWITCHING UNIT ELECTRODE CATHETERS | Webster Laboratories, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823434 | MIKRO-TIP CATHETER PRESSURE TRANSDUCER | Millar Instruments, Inc. | 1982-11-30 | Traditional | PDF ↗ |
| K812944 | MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. | Millar Instruments, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K802058 | MAPPING PROBE MODEL #6540 | Cardiac Pacemakers, Inc. | 1980-11-19 | Traditional | PDF ↗ |
| K770709 | PROBE, TEMPERATURE, SYSTEM, SARNS | 3M Health Care, Sarns | 1977-04-27 | Traditional | PDF ↗ |
| K770477 | CITADEL REFERENCE ELECTRODE | Sherwood Medical Industries | 1977-03-30 | Traditional | PDF ↗ |
| K770341 | TEMP. PROBE, & ELECTRONIC THERMOMETER | Electro-Catheter Corp. | 1977-02-28 | Traditional | PDF ↗ |
Product code DRF · Class II · Cardiovascular. Data: openFDA.