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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 K121629
Models IGTCFS-65-1-FEM-FT-CELECT-PT, IGTCFS-65-1-JUG-CELECT-PT, IGTCFS-65-1-UNI-FT-CELECT-PT
Device Name COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
Original Applicant
WILLIAM COOK EUROPE APS
1 geddes way
west lafayette,  IN  47906
Original Contact jennifer brown
Regulation Number870.3375
Classification Product Code
DTK  
Date Received06/04/2012
Decision Date 07/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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