Clearance Summary
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System received FDA 510(k) clearance under submission number K242429, sponsored by Becton Dickinson Inc. (Bd). The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-04-09.
- Submission: K242429
- Applicant / Sponsor: Becton Dickinson Inc. (Bd)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2025-04-09
Classification & Regulation
This clearance is catalogued under FDA product code SEF and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.