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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K153293
Device Name Extension Set
Applicant
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact Kimberly Smith
Correspondent
B.Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact Kimberly Smith
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/13/2015
Decision Date 04/06/2016
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
Recalls CDRH Recalls
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