SEF — Central Venous Catheter With Manual Insertion System Class II
FDA product code SEF covers "Central Venous Catheter With Manual Insertion System", a Class II medical device regulated under 21 CFR 880.5200. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SEF
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242429 | becton dickinson inc. (bd) | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion Syste | April 9, 2025 |