FLEXOR EVAC ASPIRATION CATHETER

Catheter, Embolectomy

COOK, INC.

The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Flexor Evac Aspiration Catheter.

Pre-market Notification Details

Device IDK073627
510k NumberK073627
Device Name:FLEXOR EVAC ASPIRATION CATHETER
ClassificationCatheter, Embolectomy
Applicant COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington,  IN  47402
ContactKaren Bradburn
CorrespondentKaren Bradburn
COOK, INC. 750 DANIELS WAY P.O. BOX 489 Bloomington,  IN  47402
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-03-04
Summary:summary

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