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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
Bbraun
2934 Central St., Suite 1a
Evanston,  IL  60201
Applicant Contact PAUL O'CONNELL
Correspondent
Bbraun
2934 Central St., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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