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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 K152765
Device Name VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
Applicant
B. Braun Interventional Systems, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact PETER FLOSDORF
Correspondent
B. Braun Interventional Systems, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact PETER FLOSDORF
Regulation Number870.3375
Classification Product Code
DTK  
Date Received09/24/2015
Decision Date 02/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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