K142199 is an FDA 510(k) clearance for the Ascendra Balloon Aortic Valvaloplasty Catheter. This device is classified as a Balloon Aortic Valvuloplasty (Class II - Special Controls, product code OZT).
Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on October 29, 2014, 79 days after receiving the submission on August 11, 2014.
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 | K142199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2014 |
| Decision Date | October 29, 2014 |
| Days to Decision | 79 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. |