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. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K153038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (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 |
| Product Code | MAV — Syringe, Balloon Inflation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |