K140943 is an FDA 510(k) clearance for the MASTRO PLUS BALLOON IN-DEFLATION DEVICE. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Beijing Demax Medical Technology Co.,Ltd (Guangzhou, CN). The FDA issued a Cleared decision on March 5, 2015, 325 days after receiving the submission on April 14, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K140943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2014 |
| Decision Date | March 05, 2015 |
| Days to Decision | 325 days |
| Submission Type | Traditional |
| 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 |