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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, intravascular, cardiovascular
510(k) Number K063217
Device Name VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
Applicant
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Applicant Contact PAUL O'CONNELL
Correspondent
B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM,  PA  18018
Correspondent Contact PAUL O'CONNELL
Regulation Number870.3375
Classification Product Code
DTK  
Date Received10/24/2006
Decision Date 01/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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