Panels › Cardiovascular › Product code DTA · Class 2
Tester, Pacemaker Electrode Function
Regulation 870.3720
0510(k)s in 12 months (10 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in DTA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biotronik, Inc. | 3 | 0 |
| Remington Medical, Inc. | 1 | 1 |
| Cardiac Pacemakers, Inc. | 1 | 0 |
| Ep Medical, Inc. | 1 | 0 |
| Medtronic, Inc. | 1 | 0 |
| Medtronic Inc. Cardiac Rhythm Managment | 0 | 1 |
| Siemens Corp. | 1 | 0 |
| St Jude Medical, Crmd | 1 | 0 |
| Vitatron Medical BV | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2017 | K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer Medtronic, Inc. | DTA |
| Dec 21, 2010 | K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 St Jude Medical, Crmd | DTA |
| Dec 20, 2007 | K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS Biotronik, Inc. | DTA |
| May 19, 2005 | K050884 | ADAPTER CABLE Remington Medical, Inc. | DTA |
| Dec 8, 2003 | K033613 | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER Biotronik, Inc. | DTA |
| Jan 27, 2003 | K022360 | ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. Biotronik, Inc. | DTA |
| Oct 21, 1993 | K933069 | MODEL EP-2 CLINICAL STIMULATOR Ep Medical, Inc. | DTA |
| Dec 2, 1981 | K812104 | SIEMENS-ELEMA PSA 376 Siemens Corp. | DTA |
| Sep 19, 1979 | K791380 | VA 1000 Vitatron Medical BV | DTA |
| May 17, 1979 | K790503 | CARDIOTEST 2200 Cardiac Pacemakers, Inc. | DTA |
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