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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 K925679
Device Name VENA CAVA FILTER SYSTEMS, MODIFICATION
Applicant
B. Braun Vena-Tech
Northwestern Univ. Rese. Park
1840 Oak Ave.
Evanston,  IL  60201
Applicant Contact PAUL O'CONNELL
Correspondent
B. Braun Vena-Tech
Northwestern Univ. Rese. Park
1840 Oak Ave.
Evanston,  IL  60201
Correspondent Contact PAUL O'CONNELL
Regulation Number870.3375
Classification Product Code
DTK  
Date Received11/10/1992
Decision Date 11/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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