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 |
|---|---|---|---|
| Feb 10, 1993 | K923915 | TORQR SERIES DIAGNOSTIC EP CATHETERS Cardiorhythm | DRF |
| Jun 18, 1992 | K911065 | ARROW QUADPOLAR MAPPING/PACING CATHETER Arrow Intl., Inc. | DRF |
| Mar 9, 1992 | K915640 | VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER Arrhythmia Technologies, Inc. | DRF |
| Mar 9, 1992 | K915563 | DIAGNOSTIC EP CATHETER Arrhythmia Technologies, Inc. | DRF |
| Mar 4, 1992 | K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN Daig Corp. | DRF |
| Feb 7, 1992 | K915159 | PEDIATRIC MULTI-FUNCTION ELECTRODES Zmi Corp. | DRF |
| Nov 22, 1991 | K914460 | MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES Medtronic Vascular | DRF |
| Oct 25, 1991 | K913375 | TORQUE TUBE STEEROCATH(TM) Ep Technologies, Inc. | DRF |
| Oct 9, 1991 | K904747 | PEI PLAQUE ELECTRODE ARRAY Prucka Engineering, Inc. | DRF |
| May 7, 1991 | K911140 | BARD(R) ENDOCARDIAL BALLOON ARRAY C.R. Bard, Inc. | DRF |
| Mar 29, 1991 | K905831 | ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH Arzco Medical Electronics, Inc. | DRF |
| Jan 18, 1991 | K903136 | ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER Arzco Medical Electronics, Inc. | DRF |
| Oct 12, 1990 | K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER Ep Technologies, Inc. | DRF |
| Jul 6, 1990 | K902228 | MODIFIED EPICARDIAL ARRAY C.R. Bard, Inc. | DRF |
| May 7, 1990 | K900765 | STEEROCATH(TM) Ep Technologies, Inc. | DRF |
| Mar 14, 1990 | K900452 | QUATTRO CATHETER Ep Technologies, Inc. | DRF |
| Dec 13, 1989 | K895916 | PE INTERCARDIAC MAPPING SYSTEM (ICMS) Prucka Engineering, Inc. | DRF |
| Sep 18, 1989 | K894500 | DAIG ELECTROPHYSIOLOGY CATHETER Daig Corp. | DRF |
| Jul 14, 1989 | K893611 | BARD PLAQUE ELECTRODE ARRAY Bard Electrophysiology | DRF |
| Jun 12, 1989 | K892207 | FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED Ep Technologies, Inc. | DRF |
| Jun 5, 1989 | K891908 | BARD(R) TIP DEFLECTING ELECTRODE CATHETER C.R. Bard, Inc. | DRF |
| Oct 4, 1988 | K881966 | ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER C.R. Bard, Inc. | DRF |
| Jul 18, 1988 | K881853 | FRANZ CATHETER Ep Technologies, Inc. | DRF |
| Jan 7, 1988 | K873995 | BARD DESAI CATHETER ELECTRODE C.R. Bard, Inc. | DRF |
| Dec 29, 1987 | K874208 | BARD OCTAPOLAR ELECTRODE CATHETER C.R. Bard, Inc. | DRF |
| Oct 9, 1987 | K872231 | BARD EPICARDIAL ELECTRODE ARRAY C.R. Bard, Inc. | DRF |
| Jan 2, 1985 | K844805 | ELECATH GALLAGHER MAPPING CATHETER Electro-Catheter Corp. | DRF |
| May 9, 1984 | K834602 | SWITCHING UNIT ELECTRODE CATHETER Webster Laboratories, Inc. | DRF |
| Jun 30, 1983 | K831528 | MODEL TP THERMISTOR PROBE Scimed Life Systems, Inc. | DRF |
| Jan 14, 1983 | K823361 | SWITCHING UNIT ELECTRODE CATHETERS Webster Laboratories, Inc. | DRF |
| Nov 30, 1982 | K823434 | MIKRO-TIP CATHETER PRESSURE TRANSDUCER Millar Instruments, Inc. | DRF |
| Nov 16, 1981 | K812944 | MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. Millar Instruments, Inc. | DRF |
| Nov 19, 1980 | K802058 | MAPPING PROBE MODEL #6540 Cardiac Pacemakers, Inc. | DRF |
| Apr 27, 1977 | K770709 | PROBE, TEMPERATURE, SYSTEM, SARNS 3M Health Care, Sarns | DRF |
| Mar 30, 1977 | K770477 | CITADEL REFERENCE ELECTRODE Sherwood Medical Industries | DRF |
| Feb 28, 1977 | K770341 | TEMP. PROBE, & ELECTRONIC THERMOMETER Electro-Catheter Corp. | DRF |
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