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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 K073528
Device Name VENA CAVA FILTER
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact MOLLY BUSENBANK
Correspondent
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact MOLLY BUSENBANK
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/17/2007
Decision Date 02/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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