NKU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REPROCESSED BALOON INFLATION DEVICE (K053188) | Sterilmed, Inc. | 2006-05-04 |
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Every clearance here is in the API, with alerts when new ones post.