MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT

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 Everst 30 Inflation Device/survival Kit.

Pre-market Notification Details

Device IDK960983
510k NumberK960983
Device Name:MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
ClassificationSyringe, Balloon Inflation
Applicant MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactJoseph O Magliozzi Rac
CorrespondentJoseph O Magliozzi Rac
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 Received1996-03-11
Decision Date1996-05-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169014817 K960983 000
00643169014800 K960983 000

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