COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR

Filter, Intravascular, Cardiovascular

WILLIAM COOK EUROPE APS

The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Cook Celect Platinum Vena Cava Filter Set For Femoral Approach Cook Celect Platium Vena Cava Filter Set For Jugular Appr.

Pre-market Notification Details

Device IDK121629
510k NumberK121629
Device Name:COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
ClassificationFilter, Intravascular, Cardiovascular
Applicant WILLIAM COOK EUROPE APS 1 Geddes Way West Lafayette,  IN  47906
ContactJennifer Brown
CorrespondentJennifer Brown
WILLIAM COOK EUROPE APS 1 Geddes Way West Lafayette,  IN  47906
Product CodeDTK  
CFR Regulation Number870.3375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-04
Decision Date2012-07-03
Summary:summary

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