K143522 is an FDA 510(k) clearance for the Presto Inflation Device. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 12, 2015, 31 days after receiving the submission on December 12, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K143522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2014 |
| Decision Date | January 12, 2015 |
| Days to Decision | 31 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 |