Submission Details
| 510(k) Number | K152613 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
True Flow Valvuloplasty Perfusion Catheter
Jan 2016
Decision
127d
Days
Class 2
Risk
About This 510(k) Submission
K152613 is an FDA 510(k) clearance for the True Flow Valvuloplasty Perfusion Catheter, 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 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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