DTF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tools, Pacemaker Service
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3730
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2003: 1 · 2004: 1 · 2005: 9
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 |
|---|---|---|
| TORQUE HEX WRENCH (K875147) | Cardiac Pacemakers, Inc. | 1988-01-27 |
| WRENCH, GEXAGON, DRIVER (K781179) | Telectronics, Inc. | 1978-07-27 |
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Every clearance here is in the API, with alerts when new ones post.