Cleared Special

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

K153038 · Medtronic, Inc. · Cardiovascular
Apr 2016
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K153038 is an FDA 510(k) clearance for the Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on April 13, 2016, 177 days after receiving the submission on October 19, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K153038 FDA.gov
FDA Decision Cleared SESK
Date Received October 19, 2015
Decision Date April 13, 2016
Days to Decision 177 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MAV — Syringe, Balloon Inflation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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