DTA
10 FDA 510(k) clearances · Product code
121 daysmedian time to decision
192 days90th percentile
10clearances measured
FDA profile
- Official device name
- Tester, Pacemaker Electrode Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3720
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CareLink SmartSync Device Manager - Pacing System Analyzer (K163008) | Medtronic, Inc. | 2017-02-28 |
| MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (K101982) | St Jude Medical, Crmd | 2010-12-21 |
| MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (K073230) | Biotronik, Inc. | 2007-12-20 |
| ADAPTER CABLE (K050884) | Remington Medical, Inc. | 2005-05-19 |
| MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K033613) | Biotronik, Inc. | 2003-12-08 |
| 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. (K022360) | Biotronik, Inc. | 2003-01-27 |
| MODEL EP-2 CLINICAL STIMULATOR (K933069) | Ep Medical, Inc. | 1993-10-21 |
| SIEMENS-ELEMA PSA 376 (K812104) | Siemens Corp. | 1981-12-02 |
| VA 1000 (K791380) | Vitatron Medical BV | 1979-09-19 |
| CARDIOTEST 2200 (K790503) | Cardiac Pacemakers, Inc. | 1979-05-17 |
Track DTA automatically
Every clearance here is in the API, with alerts when new ones post.