Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

Syringe, Balloon Inflation

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit.

Pre-market Notification Details

Device IDK153038
510k NumberK153038
Device Name:Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
ClassificationSyringe, Balloon Inflation
Applicant MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers,  MA  01923
ContactNisarg Shah
CorrespondentNisarg Shah
MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers,  MA  01923
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-19
Decision Date2016-04-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169843042 K153038 000
00643169843035 K153038 000
00643169843028 K153038 000
00643169843011 K153038 000
00643169621923 K153038 000
00643169621916 K153038 000
00643169621909 K153038 000
00643169621893 K153038 000

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