GORE FLOW REVERSAL SYSTEM

Temporary Carotid Catheter For Embolic Capture

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Flow Reversal System.

Pre-market Notification Details

Device IDK083300
510k NumberK083300
Device Name:GORE FLOW REVERSAL SYSTEM
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant W.L. GORE & ASSOCIATES,INC 3250 W. KILTIE LANE Flagstaff,  AZ  86005
ContactMichelle A Wells
CorrespondentMichelle A Wells
W.L. GORE & ASSOCIATES,INC 3250 W. KILTIE LANE Flagstaff,  AZ  86005
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-10
Decision Date2009-02-04
Summary:summary

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