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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 K010485
Device Name VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
Applicant
B BRAUN
2934 CENTRAL STREET, SUITE 1A
EVANSTON,  IL  60201
Applicant Contact PAUL O'CONNELL
Correspondent
B BRAUN
2934 CENTRAL STREET, SUITE 1A
EVANSTON,  IL  60201
Correspondent Contact PAUL O'CONNELL
Regulation Number870.3375
Classification Product Code
DTK  
Date Received02/20/2001
Decision Date 05/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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