K153672 is an FDA 510(k) clearance for the basixTOUCH40 Inflation Syringe. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 20, 2016, 30 days after receiving the submission on December 21, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K153672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 21, 2015 |
| Decision Date | January 20, 2016 |
| Days to Decision | 30 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 |