KFJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Materials, Repair Or Replacement, Pacemaker
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3710
- Medical specialty
- Cardiovascular
- Flags
- Implant
- Adverse events (MAUDE)
- 2011: 6
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 |
|---|---|---|
| UNIVERSAL TERMINAL CAP, 3.2MM (K913919) | Telectronics Pacing Systems, Inc. | 1991-12-31 |
| MEDTRONIC MODEL 5867-1A (K852236) | Medtronic Vascular | 1985-07-11 |
| IMPLANT AID SPLICING CRIMP & SLEEVE (K813518) | Intermedics, Inc. | 1982-01-12 |
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Every clearance here is in the API, with alerts when new ones post.