GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Guardwire Temporary Occlusion And Aspiration System.

Pre-market Notification Details

Device IDK023878
510k NumberK023878
Device Name:GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
ClassificationTemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactFred L Boucher
CorrespondentFred L Boucher
MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
Product CodeNFA  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-21
Decision Date2003-01-24
Summary:summary

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