MEDTRONIC EXPORT XT CATHETER

Catheter, Embolectomy

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Export Xt Catheter.

Pre-market Notification Details

Device IDK061958
510k NumberK061958
Device Name:MEDTRONIC EXPORT XT CATHETER
ClassificationCatheter, Embolectomy
Applicant MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactKaren A Brozowski
CorrespondentKaren A Brozowski
MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-11
Decision Date2006-09-05
Summary:summary

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