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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Central Venous Catheter With Manual Insertion System
510(k) Number K242429
Device Name CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
Applicant
Becton Dickinson Inc. (Bd)
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Connor Dahl
Correspondent
Becton Dickinson Inc. (Bd)
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Connor Dahl
Regulation Number880.5200
Classification Product Code
SEF  
Date Received08/15/2024
Decision Date 04/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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