Everest 20 Inflation Device And 3-way Stopcock (AC2200);Everest 30 Inflation Device And 3-way Stopcock (AC3200);Everest 20 Survival Kit Containing:1. Everest 20 Device With 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. T

Syringe, Balloon Inflation

Medtronic Vascular

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Everest 20 Inflation Device And 3-way Stopcock (ac2200);everest 30 Inflation Device And 3-way Stopcock (ac3200);everest 20 Survival Kit Containing:1. Everest 20 Device With 3-way Stopcock, 2. Piton Y-adaptor ,3. Metal Guidewire Insertion Needle, 4. T.

Pre-market Notification Details

Device IDK220773
510k NumberK220773
Device Name:Everest 20 Inflation Device And 3-way Stopcock (AC2200);Everest 30 Inflation Device And 3-way Stopcock (AC3200);Everest 20 Survival Kit Containing:1. Everest 20 Device With 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. T
ClassificationSyringe, Balloon Inflation
Applicant Medtronic Vascular 37A Cherry Hill Drive Danvers,  MA  01923
ContactNikita Ciandra Vaz
CorrespondentNikita Ciandra Vaz
Medtronic Vascular 37A Cherry Hill Drive Danvers,  MA  01923
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-16
Decision Date2022-04-13

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