FFH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Collector, Urine, Pediatric, For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2002: 2 · 2018: 14
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 |
|---|---|---|
| PEDIATRIC AND INFANT CATH KITS (K905016) | Davol, Inc. | 1990-12-20 |
| PEDIATRIC DRAIN BAG (K896581) | Laytech Medical Co. | 1990-01-31 |
| INTECARE PEDIATRIC URINE COLLECTOR (K871789) | Mercury Enterprises, Inc. | 1987-08-10 |
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Every clearance here is in the API, with alerts when new ones post.