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 |
|---|---|---|---|
| Jul 28, 1978 | K780809 | GENERATOR, PULSE MODELS 5920/5921 Medtronic Vascular | DXY |
| Jul 28, 1978 | K780741 | GENERATOR, PULSE, DEMAND, MODEL 5996 Medtronic Vascular | DXY |
| Jul 27, 1978 | K781042 | PROLITH 23S PACEMAKER Edwards Pacemaker Systems | DXY |
| Jul 27, 1978 | K780781 | STILITH CARDIAC PACEMAKERS-M. 60 & 120 R.E. Brown Co., Inc. | DXY |
| Jul 27, 1978 | K780561 | VENTRICULAR INHIBITED PULSE GENERATOR Medtronic Vascular | DXY |
| Jul 27, 1978 | K780420 | GENERATOR, PULSE, CARDIAC, IMPLANTABLE Telectronics, Inc. | DXY |
| Jul 7, 1978 | K780421 | GENERATOR, PULSE, CARDIAC, IMPLANTABLE Telectronics, Inc. | DXY |
| Jun 30, 1978 | K780780 | MICROPULSE 22S PACEMAKER Edwards Pacemaker Systems | DXY |
| Jun 30, 1978 | K780453 | STANICOR THETA MODEL 221 CARDIAC PACER Cordis Corp. | DXY |
| May 18, 1978 | K780327 | GENERATORS, ATRIAL INHIBITED PULSE Medtronic Vascular | DXY |
| May 16, 1978 | K780777 | BAGS, PLASTIC, STERILE FOR GENERATORS Telectronics, Inc. | DXY |
| Apr 5, 1978 | K780437 | PACEMAKER, MODEL 252, C-MOS Intermedics, Inc. | DXY |
| Mar 15, 1978 | K780238 | PACEMAKER, PROLITH 23U. PULSE GENERATOR Edwards Pacemaker Systems | DXY |
| Feb 13, 1978 | K780113 | CARDIAC PULSE GENERATOR, MODEL 160B Telectronics, Inc. | DXY |
| Jan 30, 1978 | K780091 | MICROPULSE 22U Edwards Pacemaker Systems | DXY |
| Jan 30, 1978 | K780066 | CARDIAC PACER, MODEL 208 Cordis Corp. | DXY |
| Jan 30, 1978 | K772241 | PULSE GENERATOR, BIPOLAR, DEMAND Cardiac Pacemakers, Inc. | DXY |
| Jan 30, 1978 | K772240 | PULSE GENERATOR, UNIPOLAR, DEMAND Cardiac Pacemakers, Inc. | DXY |
| Jan 30, 1978 | K772239 | PULSE GENERATOR, BIPOLAR, PROGRAMMABLE Cardiac Pacemakers, Inc. | DXY |
| Jan 30, 1978 | K772238 | PULSE GENERATOR, UNIPOLAR, PROGRAMABLE Cardiac Pacemakers, Inc. | DXY |
| Jan 30, 1978 | K772051 | MDL-201 Pacesetter Systems | DXY |
| Jan 30, 1978 | K772050 | TDL-100 B Pacesetter Systems | DXY |
| Jan 24, 1978 | K780061 | PULSE GENERATORS, MODELS 5972/5973 Medtronic Vascular | DXY |
| Jan 17, 1978 | K772357 | PULSE GENERATORS Medtronic Vascular | DXY |
| Jan 4, 1978 | K771786 | CARDIAC PULSE GENERATORS 5982/5983 Medtronic Vascular | DXY |
| Jan 4, 1978 | K771770 | XYREL-RA MODELS 5994/5995 Medtronic Vascular | DXY |
| Dec 20, 1977 | K772202 | PULSE GENERATOR, A-V SEQ. Medtronic Vascular | DXY |
| Nov 28, 1977 | K772010 | CARDIAC PACEMAKER C2001 Vitatron Medical BV | DXY |
| Nov 28, 1977 | K772009 | CARDIAC PACEMAKER S6001 Vitatron Medical BV | DXY |
| Nov 3, 1977 | K772057 | BIPOLAR PACEMAKER MODEL 224 Intermedics, Inc. | DXY |
| Nov 3, 1977 | K772026 | CARDIAC PULSE GENERATOR, MODEL 150L Telectronics, Inc. | DXY |
| Nov 2, 1977 | K771992 | L-501 CARDIAC PACEMAKER Coratomic, Inc. | DXY |
| Nov 2, 1977 | K771987 | MICROPULSE 26U PULSE GENERATOR Edwards Pacemaker Systems | DXY |
| Sep 12, 1977 | K771670 | IMPLANTED PACEMAKER PLUSE GENERATOR Telectronics, Inc. | DXY |
| Sep 12, 1977 | K771626 | PACEMAKER MODEL 251 Intermedics, Inc. | DXY |
| Aug 22, 1977 | K771538 | LITHICRON MODEL 3-70C-B PULSE GENERATOR Medcor, Inc. | DXY |
| Jul 21, 1977 | K771262 | PACEMAKER & CARDIAC LEAD, BIPOLAR Arco Medical Products Co. | DXY |
| Jun 20, 1977 | K770951 | CARDIAC PACERS W/NARROW PULSE WIDTH Cordis Corp. | DXY |
| Jun 20, 1977 | K770881 | GENERATOR, PULSE, BIPOLAR 3608 Cardiac Pacemakers, Inc. | DXY |
| Jun 20, 1977 | K770880 | GENERATOR, PULSE, UNIPOLAR, #508 Cardiac Pacemakers, Inc. | DXY |
| Apr 26, 1977 | K770716 | GENERATOR, PULSE, UNIPOLAR, MODEL #504 Cardiac Pacemakers, Inc. | DXY |
| Apr 26, 1977 | K770661 | GENERATOR, PULSE, IMPLANTABLE Med Telectronics , Ltd. | DXY |
| Apr 26, 1977 | K770657 | GENERATOR, PULSE, CARDIAC 2LU Edwards Pacemaker Systems | DXY |
| Apr 26, 1977 | K770656 | GENERATOR, PULSE, CARDIAC 20U Edwards Pacemaker Systems | DXY |
| Apr 25, 1977 | K770715 | GENERATOR, PULSE, BIPOLAR, MODEL #604 Cardiac Pacemakers, Inc. | DXY |
| Apr 7, 1977 | K770507 | PULSE GENERATOR, LITKICRON MODEL 3-70H Medcor, Inc. | DXY |
| Apr 5, 1977 | K770419 | CENTURION Johnson & Johnson Professionals, Inc. | DXY |
| Mar 28, 1977 | K770559 | C-L0L CARDIAC PACEMAKER Coratomic, Inc. | DXY |
| Mar 9, 1977 | K770212 | PROLITH MODEL 21S CARDIAC PULSE GEN. Edwards Pacemaker Systems | DXY |
| Mar 7, 1977 | K770211 | MICROPULSE MODEL 20S Edwards Pacemaker Systems | DXY |
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