EXPORT XT CATHETER, EXPORT AP CATHETER

Catheter, Embolectomy

MEDTRONIC INC.

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

Pre-market Notification Details

Device IDK120808
510k NumberK120808
Device Name:EXPORT XT CATHETER, EXPORT AP CATHETER
ClassificationCatheter, Embolectomy
Applicant MEDTRONIC INC. 35-37A CHERRY HILL DRIVE Danvers,  MA  01923 -5186
ContactAnu Gaur
CorrespondentAnu Gaur
MEDTRONIC INC. 35-37A CHERRY HILL DRIVE Danvers,  MA  01923 -5186
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-16
Decision Date2012-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994431745 K120808 000

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