EXPORT CATHETER

Catheter, Embolectomy

MEDTRONIC VASCULAR

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

Pre-market Notification Details

Device IDK040869
510k NumberK040869
Device Name:EXPORT CATHETER
ClassificationCatheter, Embolectomy
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 CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-02
Decision Date2004-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994416155 K040869 000

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