K133795 is an FDA 510(k) clearance for the SUMMED INFLATION DEVICE KIT. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on December 12, 2014, 364 days after receiving the submission on December 13, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K133795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2013 |
| Decision Date | December 12, 2014 |
| Days to Decision | 364 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 |