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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 K140311
Device Name CARESITE LUER ACCESS DEVICE
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 Received02/07/2014
Decision Date 05/07/2014
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
Recalls CDRH Recalls
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