Submission Details
| 510(k) Number | K142199 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Ascendra Balloon Aortic Valvaloplasty Catheter
Oct 2014
Decision
79d
Days
Class 2
Risk
About This 510(k) Submission
K142199 is an FDA 510(k) clearance for the Ascendra Balloon Aortic Valvaloplasty Catheter, 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 review panel. Regulated under 21 CFR 870.1255.
Device Classification
| 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. |
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