COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

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 Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set.

Pre-market Notification Details

Device IDK073374
510k NumberK073374
Device Name:COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
ClassificationFilter, Intravascular, Cardiovascular
Applicant WILLIAM COOK EUROPE APS 750 DANIELS WAY P.O. BOX 489 Bloomington,  IN  47402 -0489
ContactMolly Busenbark
CorrespondentMolly Busenbark
WILLIAM COOK EUROPE APS 750 DANIELS WAY P.O. BOX 489 Bloomington,  IN  47402 -0489
Product CodeDTK  
CFR Regulation Number870.3375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-03
Decision Date2008-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002483781 K073374 000
00827002483736 K073374 000
00827002483729 K073374 000

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