FDA 510(k) Application Details - K242429

Device Classification Name	More FDA Info for this Device
510(K) Number	K242429
Device Name	CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
Applicant	Becton Dickinson Inc. (BD) 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Connor Dahl Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2024
Decision Date	04/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review