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 |
|---|---|---|---|
| Jan 10, 2025 | K241781 | Solo Pace Control Solo Pace, Inc. | DTE |
| Jan 7, 2024 | K232721 | Lifetech Cardio Temporary Pacemaker Shenzhen Lifetech Cardio Medical Electronics Co., Ltd., CN | DTE |
| May 13, 2020 | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. | DTE |
| Apr 30, 2019 | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. | DTE |
| Feb 28, 2019 | K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker Shenzhen Lifetech Cardio Medical Electronics Co., Ltd., CN | DTE |
| Aug 21, 2018 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. | DTE |
| Apr 19, 2018 | K180873 | Medtronic Model 53401 External Pulse Generator (EPG) Medtronic, Inc. | DTE |
| Oct 18, 2016 | K162054 | Medtronic Temporary External Pacemaker 53401 Medtronic, Inc. | DTE |
| Oct 12, 2016 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. | DTE |
| Feb 18, 2015 | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. | DTE |
| Oct 31, 2013 | K132924 | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) Medtronic, Inc. | DTE |
| Apr 9, 2013 | K123916 | PSA SERIES Osypka Medical, Inc. | DTE |
| Oct 20, 2004 | K042708 | ERA 3000 PACING SYSTEM ANALYZER Biotronik, Inc. | DTE |
| Oct 31, 2003 | K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR Osypka Medical, Inc. | DTE |
| Jun 11, 2003 | K023080 | GALIX PACESTAR Galix Biomedical Instrumentation, Inc. | DTE |
| Oct 3, 2002 | K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES Osypka Medical, Inc. | DTE |
| Jun 14, 2002 | K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE Osypka Medical, Inc. | DTE |
| Sep 12, 2001 | K011980 | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 Pace Medical | DTE |
| Oct 18, 2000 | K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V Pace Medical | DTE |
| Jun 27, 2000 | K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 Pace Medical | DTE |
| Aug 29, 1997 | K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM Paladin Medical, Inc. | DTE |
| Jul 14, 1997 | K971474 | MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL Medtronic Vascular | DTE |
| Jul 10, 1997 | K964190 | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER Biotronik, Inc. | DTE |
| Jun 4, 1997 | K970497 | PACE 101H Sulzer Oscor, Inc. | DTE |
| Jun 5, 1996 | K960676 | ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004 Zoll Medical Corp | DTE |
| Nov 1, 1994 | K940467 | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 Remington Medical, Inc. | DTE |
| Oct 18, 1994 | K934016 | POWERCHARGER Zoll Medical Corp | DTE |
| Sep 27, 1994 | K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER Pace Medical | DTE |
| May 19, 1993 | K923621 | EXTERNAL DEMAND PACEMAKER Oscor Medical Corp. | DTE |
| Aug 14, 1992 | K923398 | CPI MODEL 2215 Seamed Corp. | DTE |
| Feb 7, 1992 | K915364 | CHRONOCOR VI MODEL 5012 Seamed Corp. | DTE |
| Nov 19, 1991 | K913805 | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER Pace Medical | DTE |
| Sep 3, 1991 | K912507 | CPI MODEL 2215 & SEAMED MODEL 3400 Seamed Corp. | DTE |
| Feb 25, 1991 | K910237 | MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR Medtronic Vascular | DTE |
| Jul 19, 1990 | K902679 | MODELS 4201, 4231 & 4235 EXTENSION CABLES Pace Medical | DTE |
| Jul 17, 1990 | K900220 | TRANS-PACE 100 Synchromed Corp. | DTE |
| Jan 24, 1990 | K896352 | MODEL EC4542G MINIATURE Pace Medical | DTE |
| Jun 20, 1989 | K893633 | MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE Medtronic Vascular | DTE |
| Nov 9, 1988 | K883930 | SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY Seamed Corp. | DTE |
| Jul 31, 1987 | K872551 | SEAMED MODEL 3200 Seamed Corp. | DTE |
| Jun 10, 1987 | K871915 | MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 Pace Medical | DTE |
| Mar 11, 1987 | K853194 | ERA-20 Biotronik Sales, Inc. | DTE |
| Mar 3, 1987 | K870323 | MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER Pace Medical | DTE |
| Dec 10, 1986 | K863903 | SEA MED MODEL 6000 Seamed Corp. | DTE |
| Jan 16, 1986 | K854648 | SEAMED MODEL 4000 Seamed Corp. | DTE |
| Jul 16, 1985 | K850822 | CHRONOCOR V EXTERNAL PACER, MODEL 297A Seamed Corp. | DTE |
| Feb 1, 1985 | K843807 | SEAMED MODEL 6000 Seamed Corp. | DTE |
| Feb 1, 1985 | K843777 | SEAMED 4000 Seamed Corp. | DTE |
| Dec 16, 1983 | K831768 | EXTERNAL PULSE GENERATOR FOR TEMP. STIM Oscor, Inc. | DTE |
| Aug 31, 1983 | K831381 | RAPID ATRIAL PACER Seamed Corp. | DTE |
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