Panels › Cardiovascular › Product code DRF · Class 2
Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation 870.1220
2510(k)s in 12 months (186 all time)
0recalls in 12 months (26 all time)
19recalls that name a 510(k)
Top companies in DRF
| Company | 510(k)s | Recalls |
|---|---|---|
| Biosense Webster, Inc. | 19 | 15 |
| Boston Scientific | 14 | 5 |
| St Jude Medical | 14 | 1 |
| Ep Technologies, Inc. | 12 | 0 |
| C.R. Bard, Inc. | 11 | 0 |
| Irvine Biomedical, Inc. | 11 | 0 |
| Cordis Webster, Inc. | 8 | 0 |
| Innovative Health, LLC | 6 | 0 |
| Medtronic | 5 | 1 |
| Cardima, Inc. | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 1999 | K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 Cordis Webster, Inc. | DRF |
| Jul 15, 1999 | K991001 | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER Ep Medsystems | DRF |
| Jun 3, 1999 | K990958 | ORTHOGONAL EP CATHETERS Irvine Biomedical, Inc. | DRF |
| May 11, 1999 | K972803 | TRACER O-T-W MAPPING DEVICE Cardima, Inc. | DRF |
| Feb 22, 1999 | K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER Ep Medsystems | DRF |
| Dec 22, 1998 | K983653 | RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D Cardiac Pathways Corp. | DRF |
| Oct 29, 1998 | K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 Cardima, Inc. | DRF |
| Aug 10, 1998 | K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 Cordis Webster, Inc. | DRF |
| Aug 5, 1998 | K981642 | STABLEMAPR STEERABLE INTRACARDIAC CATHETERS Medtronic Cardiorhythm | DRF |
| Jul 25, 1998 | K982232 | MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc. | DRF |
| Jul 1, 1998 | K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER Cardima, Inc. | DRF |
| May 28, 1998 | K980961 | CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04. Cordis Webster, Inc. | DRF |
| Apr 20, 1998 | K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. J-Lloyd Medical, Inc. | DRF |
| Apr 20, 1998 | K971504 | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER J-Lloyd Medical, Inc. | DRF |
| Nov 4, 1997 | K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) Cardima, Inc. | DRF |
| Oct 23, 1997 | K971265 | VIKING DIAGNOSTIC ELECTRODE CATHETER C.R. Bard, Inc. | DRF |
| Aug 11, 1997 | K965066 | ARRHYTHMIA MAPPING SYSTEM (8100/8300) Cardiac Pathways Corp. | DRF |
| Jun 25, 1997 | K963074 | HARMAC QUADPOLAR MAPPING PACING CATHETER Harmac Medical Products, Inc. | DRF |
| Apr 11, 1997 | K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM Irvine Biomedical, Inc. | DRF |
| Jan 29, 1997 | K955847 | GYRO TIP EP CATHETER Cardiac Assist Devices, Inc. | DRF |
| Jan 29, 1997 | K955802 | PATHFINDER Cardima, Inc. | DRF |
| Jan 23, 1997 | K964272 | PERFORMR SERIES EP DIAGNOSTIC CATHETERS Medtronic Cardiorhythm | DRF |
| Oct 22, 1996 | K954651 | ELECTRODE RECORDING CATHETER Boston Scientific Corp | DRF |
| Sep 18, 1996 | K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER Cordis Webster, Inc. | DRF |
| Sep 17, 1996 | K962307 | RHYDER DIAGNOSTIC CATHETER Fidus Medical Technology Corp. | DRF |
| Apr 15, 1996 | K960542 | NOGA Biosense, Ltd., IL | DRF |
| Apr 15, 1996 | K953185 | PLATINUM SERIES EP DIAGNOSTIC CATHETERS Medtronic Cardiorhythm | DRF |
| Mar 25, 1996 | K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER Cordis Webster, Inc. | DRF |
| Mar 11, 1996 | K953750 | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Boston Scientific Corp | DRF |
| Dec 21, 1995 | K954390 | CORDIS WESTER STAR CATHETER Cordis Webster, Inc. | DRF |
| Nov 30, 1995 | K953651 | DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM Arrow Intl., Inc. | DRF |
| Nov 22, 1995 | K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER Cordis Webster, Inc. | DRF |
| Aug 8, 1995 | K945229 | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS Arrow Intl., Inc. | DRF |
| Jul 18, 1995 | K946333 | IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER Irvine Biomedical, Inc. | DRF |
| May 31, 1995 | K932388 | HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER Heart Rhythm Technologies, Inc. | DRF |
| May 10, 1995 | K951347 | MARINR SERIES EP DIAGNOSTI CATHETERS Medtronic Cardiorhythm | DRF |
| May 4, 1995 | K951744 | LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS Boston Scientific Corp | DRF |
| May 4, 1995 | K933417 | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER Echocath, Inc. | DRF |
| Apr 19, 1995 | K943257 | TIP DEFLECTOR (GENESIS) Electro-Catheter Corp. | DRF |
| Apr 19, 1995 | K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION Electro-Catheter Corp. | DRF |
| Apr 19, 1995 | K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION Electro-Catheter Corp. | DRF |
| Dec 27, 1994 | K942379 | DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER Daig Corp. | DRF |
| Aug 2, 1994 | K940167 | DIAGNOSTIC I CATHETER Ep Technologies, Inc. | DRF |
| Jul 27, 1994 | K940168 | DIAGNOSTIC II CATHETER Ep Technologies, Inc. | DRF |
| Jun 6, 1994 | K931794 | MARINR SERIES EP DIAGNOSTIC CATHETERS Medtronic Cardiorhythm | DRF |
| Dec 16, 1993 | K924109 | STEEROCATH II Ep Technologies, Inc. | DRF |
| Dec 16, 1993 | K924108 | TRACFINDER II Ep Technologies, Inc. | DRF |
| Dec 6, 1993 | K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER Endo-Therapeutics, Inc. | DRF |
| Sep 3, 1993 | K924163 | EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC Boston Scientific Corp | DRF |
| Feb 10, 1993 | K923916 | VOYAGR SERIES DIAGNOSTIC EP CATHETERS Cardiorhythm | DRF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.