GCC
5 FDA 510(k) clearances · Product code
63 daysmedian time to decision
72 days90th percentile
5clearances measured
FDA profile
- Official device name
- Dilator, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 3 · 1997: 1 · 1999: 5 · 2000: 9 · 2001: 3 · 2009: 8
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 |
|---|---|---|
| INTRAVASCULAR RETRIEVAL DEVICE (K981061) | Med Institute, Inc. | 1998-05-26 |
| BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (K922354) | Med Institute, Inc. | 1992-07-30 |
| BYRD STAINLESS STEEL DILATOR (K902502) | Medical Engineering and Development Institute | 1990-08-07 |
| BYRD EXTRACTOR SET (K893480) | Medical Engineering and Development Institute | 1989-06-23 |
| VAN-TEC FASCIAL DILATOR (K820865) | Van-Tec, Inc. | 1982-05-05 |
Track GCC automatically
Every clearance here is in the API, with alerts when new ones post.