Panels › Cardiovascular › Product code DTE · Class 2
Pulse-Generator, Pacemaker, External
Regulation 870.3600
0510(k)s in 12 months (65 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in DTE
| Company | 510(k)s | Recalls |
|---|---|---|
| Seamed Corp. | 13 | 0 |
| Pace Medical | 9 | 0 |
| Medtronic, Inc. | 8 | 0 |
| Osypka Medical, Inc. | 4 | 2 |
| Medtronic Vascular | 5 | 0 |
| Cynergy | 4 | 0 |
| Telectronics, Inc. | 3 | 0 |
| Biotronik, Inc. | 2 | 0 |
| Intermedics, Inc. | 2 | 0 |
| Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 1982 | K823048 | SEA MED MODEL 880 Seamed Corp. | DTE |
| Jul 6, 1982 | K821791 | EXTERNAL PULSE GENERATOR - EV4542 American Pacemaker Corp. | DTE |
| Jun 3, 1982 | K820570 | SEAMED, #540 - SIEMENS, #146F TELECTRO Seamed Corp. | DTE |
| Jul 1, 1981 | K811092 | STERILE PACKAGING Telectronics, Inc. | DTE |
| Apr 1, 1981 | K810566 | SIEMENS MODEL 146-146A EXTERNAL PULSE G Cynergy | DTE |
| Feb 23, 1981 | K803313 | PACING SYSTEM ANALYZER Medtronic Vascular | DTE |
| Nov 19, 1980 | K802221 | CHRONOCOR IV MODEL 250 Cordis Corp. | DTE |
| Oct 31, 1980 | K801055 | COMPUPACE, 524-01 PACER SYSTEM COMPUTER Intermedics, Inc. | DTE |
| Oct 23, 1980 | K801953 | EXTERNAL, TEMP. PORTABLE CARDIAC GENER Telectronics, Inc. | DTE |
| Sep 16, 1980 | K801596 | CYNERGY MODEL 184 Cynergy | DTE |
| Jan 31, 1980 | K792536 | CYNERGY MODEL 182 Cynergy | DTE |
| Jan 29, 1980 | K800088 | PACEMAKER ELECTRODE INSERTER AIDE Telectronics, Inc. | DTE |
| Nov 30, 1979 | K792223 | PACESETTER MODEL 350 Cynergy | DTE |
| Dec 29, 1978 | K782108 | MEDTRONIC MODEL 546 Medtronic Vascular | DTE |
| Dec 11, 1978 | K781327 | PULSE GENERATOR, MODEL 240, EXTERNAL Intermedics, Inc. | DTE |
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