DTA — Tester, Pacemaker Electrode Function Class II
FDA product code DTA covers "Tester, Pacemaker Electrode Function", a Class II medical device regulated under 21 CFR 870.3720. Submissions are reviewed by the Cardiovascular panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTA
- Device Class
- Class II
- Regulation Number
- 870.3720
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163008 | medtronic | CareLink SmartSync Device Manager - Pacing System Analyzer | February 28, 2017 |
| K101982 | st jude medical, crmd | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | December 21, 2010 |
| K073230 | biotronik | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | December 20, 2007 |
| K050884 | remington medical | ADAPTER CABLE | May 19, 2005 |
| K033613 | biotronik | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | December 8, 2003 |
| K022360 | biotronik | ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA | January 27, 2003 |
| K933069 | ep medical | MODEL EP-2 CLINICAL STIMULATOR | October 21, 1993 |
| K812104 | siemens | SIEMENS-ELEMA PSA 376 | December 2, 1981 |
| K791380 | vitatron medical | VA 1000 | September 19, 1979 |
| K790503 | cardiac pacemakers | CARDIOTEST 2200 | May 17, 1979 |