SEF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Central Venous Catheter With Manual Insertion System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Medical specialty
- General Hospital
- FDA definition
- A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System (K242429) | Becton Dickinson Inc. (Bd) | 2025-04-09 |
Track SEF automatically
Every clearance here is in the API, with alerts when new ones post.