Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit— 510(k) K153038

Name: FDA 510(k) clearance K153038
Creator: U.S. Food and Drug Administration
Published: 2016-04-13

Unknown

Medtronic, Inc.

FDA 510(k) clearance K153038 for Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit, Unknown on 2016-04-13. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code MAV
Device class: Class 2
Regulation: 21 CFR 870.1650
Advisory panel: Cardiovascular
Date received: 2015-10-19
Decision date: 2016-04-13
Decision: Unknown
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.