FKA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dilator, Vessel
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1
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 |
|---|---|---|
| SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT (K022620) | Spire Biomedical, Inc. | 2002-10-11 |
| VAS-CATH DUALATOR(TM) VESSEL DILATOR (K914210) | Vas-Cath, Inc. | 1993-07-01 |
| VESSEL DILATORS (K910502) | Akcess Medical Products, Inc. | 1991-04-29 |
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Every clearance here is in the API, with alerts when new ones post.