Panels › Cardiovascular › Product code DXY · Class 3
Implantable Pacemaker Pulse-Generator
Regulation 870.3610
0510(k)s in 12 months (461 all time)
0recalls in 12 months (75 all time)
1recalls that name a 510(k)
Top companies in DXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 59 | 0 |
| Intermedics, Inc. | 52 | 0 |
| Telectronics, Inc. | 47 | 0 |
| Cardiac Pacemakers, Inc. | 37 | 0 |
| Guidant Corp-Cpi Division | 0 | 32 |
| Pacesetter Systems | 28 | 0 |
| Cook Pacemaker Corp. | 24 | 0 |
| Ela Medical, Inc. | 22 | 2 |
| Biotronik Sales, Inc. | 22 | 0 |
| Cordis Corp. | 21 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 1989 | K885267 | VS-1 MODEL NUMBER 251K PULSE GENERATOR Pacesetter Systems | DXY |
| Mar 10, 1989 | K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE Cardiac Pacemakers, Inc. | DXY |
| Feb 10, 1989 | K884733 | AFP MODEL 262T PULSE GENERATOR Pacesetter Systems | DXY |
| Jan 26, 1989 | K884411 | OPTIMA MPT AND SPT PACEMAKERS Telectronics, Inc. | DXY |
| Jan 25, 1989 | K883037 | UNILITH 3 MODELS 7580/7583/7680/7683 Ela Medical, Inc. | DXY |
| Jan 13, 1989 | K883750 | VENTRALITH I Bio Pace Technology, Inc. | DXY |
| Nov 17, 1988 | K884215 | MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 Medtronic Vascular | DXY |
| Nov 17, 1988 | K883755 | MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS Medtronic Vascular | DXY |
| Nov 14, 1988 | K882391 | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 Ela Medical, Inc. | DXY |
| Oct 17, 1988 | K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER Cardiac Control Systems, Inc. | DXY |
| Sep 23, 1988 | K882427 | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 Ela Medical, Inc. | DXY |
| Sep 14, 1988 | K883087 | PROLOG MP 658M PULSE GENERATOR Pacesetter Systems | DXY |
| Sep 12, 1988 | K882476 | OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 Ela Medical, Inc. | DXY |
| Sep 12, 1988 | K882474 | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 Ela Medical, Inc. | DXY |
| Jul 22, 1988 | K881904 | CHANGE TO CATHODE POWDER SPECIFICATION Telectronics and Cordis Pacing Systems | DXY |
| Jul 18, 1988 | K881837 | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D Telectronics, Inc. | DXY |
| May 26, 1988 | K881711 | VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. Telectronics and Cordis Pacing Systems | DXY |
| May 6, 1988 | K880898 | MULTICOR AND PACEMAKERS Tpl-Cordis, Inc. | DXY |
| Apr 11, 1988 | K880326 | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS Cardiac Control Systems, Inc. | DXY |
| Mar 31, 1988 | K880422 | MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER Cardiac Control Systems, Inc. | DXY |
| Feb 22, 1988 | K880432 | VICOR PACER, MODEL 410A Tpl-Cordis, Inc. | DXY |
| Jan 7, 1988 | K873158 | MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS Tpl-Cordis, Inc. | DXY |
| Dec 29, 1987 | K874158 | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. Cardiac Control Systems, Inc. | DXY |
| Nov 23, 1987 | K874394 | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. Intermedics, Inc. | DXY |
| Nov 4, 1987 | K872779 | PROLOG MP PULSE GENERATORS 658K AND 658T Pacesetter Systems | DXY |
| Nov 4, 1987 | K872766 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. | DXY |
| Oct 15, 1987 | K873202 | VICOR, MODEL 410A Tpl-Cordis, Inc. | DXY |
| Oct 9, 1987 | K873528 | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS Intermedics, Inc. | DXY |
| Aug 12, 1987 | K871992 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. | DXY |
| Aug 10, 1987 | K871866 | MEDTRONIC CLASSIX MODELS 8436/8437/8438 Medtronic Vascular | DXY |
| Jun 5, 1987 | K871861 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. | DXY |
| Apr 22, 1987 | K870142 | PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR Cardio-Pace Medical, Inc. | DXY |
| Feb 19, 1987 | K865013 | ASTRA T2, T4 AND T6 Cardiac Pacemakers, Inc. | DXY |
| Feb 10, 1987 | K863898 | MULTILITH 3 MODELS 1350, 3350, 1370, 3370 Ela Medical, Inc. | DXY |
| Feb 3, 1987 | K862226 | DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS Pacesetter Systems | DXY |
| Jan 12, 1987 | K860036 | EDP-20 PACEMAKER Biotronik Sales, Inc. | DXY |
| Jan 2, 1987 | K862459 | MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE Medtronic Vascular | DXY |
| Dec 10, 1986 | K863879 | NEOS-M VS-1 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Dec 10, 1986 | K863878 | TRIOS-M VS-1 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Oct 8, 1986 | K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) Cook Pacemaker Corp. | DXY |
| Oct 8, 1986 | K863417 | CORDIS MULTICOR II MODEL 402D PACER Cordis Corp. | DXY |
| Oct 8, 1986 | K863365 | MODIFICATION OF STERILITY CYCLE PARAMETERS Coratomic, Inc. | DXY |
| Sep 24, 1986 | K863418 | MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE Intermedics, Inc. | DXY |
| Sep 4, 1986 | K862974 | ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. Medtronic Vascular | DXY |
| Aug 28, 1986 | K854790 | CERYX PACEMAKER MODELS 114, 314 & 614 Vitatron Medical BV | DXY |
| Aug 8, 1986 | K860921 | NEOS VS-1, PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Aug 4, 1986 | K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Jul 16, 1986 | K860585 | ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Jul 15, 1986 | K853771 | PINNACLE MULTI-PROGRAMMABLE PACING SYS Cardio-Pace Medical, Inc. | DXY |
| Jul 1, 1986 | K861719 | MODIFIED MODELS 8320/8322/8329/8316/8317/8318 Medtronic Vascular | DXY |
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