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510(k) K242429

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System by Becton Dickinson Inc. (Bd) — Product Code SEF

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.