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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | Bio-Detek, Inc. ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single) Terminated |
DTE | K960676 |
| Jun 29, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Single Chamber Temporary External Pacemaker, Model 53401 Terminated |
DTE | K162054 |
| Mar 31, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Dual Chamber Temporary External Pacemaker, Model 5392.
Product Usage:
The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a cl Terminated |
DTE | K132924 K150246 |
| Sep 21, 2010 | Osypka Medical Inc St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator
The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead sy Terminated |
DTE | K020896 |
| Sep 21, 2010 | Osypka Medical Inc Oscor PACE 203H, Dual-Chamber External Pulse Generator
The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for tem Terminated |
DTE | K020896 |
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