K152613 is an FDA 510(k) clearance for the True Flow Valvuloplasty Perfusion Catheter. This device is classified as a Balloon Aortic Valvuloplasty (Class II - Special Controls, product code OZT).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 19, 2016, 127 days after receiving the submission on September 14, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1255. A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve..
| 510(k) Number | K152613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2015 |
| Decision Date | January 19, 2016 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OZT — Balloon Aortic Valvuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1255 |
| Definition | A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve. |