510(k) K242429
K242429 is an FDA 510(k) premarket notification submitted by Becton Dickinson Inc. (Bd) for the device "CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System". The FDA issued a decision of Substantially Equivalent on April 9, 2025. The device falls under product code SEF (Central Venous Catheter With Manual Insertion System), a Class II device regulated under 21 CFR 880.5200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2025
- Date Received
- August 15, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Central Venous Catheter With Manual Insertion System
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
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.