K130566 is an FDA 510(k) clearance for the BASIXTOUCH. 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 June 19, 2013, 107 days after receiving the submission on March 4, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K130566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2013 |
| Decision Date | June 19, 2013 |
| Days to Decision | 107 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 |