MEDTRONIC EVEREST INFLATION DEVICE

Syringe, Balloon Inflation

MEDTRONICS INTERVENTIONAL VASCULAR

The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Everest Inflation Device.

Pre-market Notification Details

Device IDK942269
510k NumberK942269
Device Name:MEDTRONIC EVEREST INFLATION DEVICE
ClassificationSyringe, Balloon Inflation
Applicant MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactJoseph O Magliozzi
CorrespondentJoseph O Magliozzi
MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-10
Decision Date1994-10-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169014794 K942269 000
00643169014787 K942269 000

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