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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 K112119
Model IGTCFS-65-8.5-1-FEM-TULIP, IGTCFS-65-8.5-FEM-CELECT
Device Name CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
Original Applicant
WILLIAM COOK EUROPE APS
one geddes way
west lafayette,  IN  47906
Original Contact jennifer brown
Regulation Number870.3375
Classification Product Code
DTK  
Date Received07/25/2011
Decision Date 03/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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