K140745 is an FDA 510(k) clearance for the ENCORE 26 ADVANTAGE KIT. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on April 17, 2014, 23 days after receiving the submission on March 25, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K140745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | March 25, 2014 |
| Decision Date | April 17, 2014 |
| Days to Decision | 23 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 |