Submission Details
| 510(k) Number | K172932 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2017 |
| Decision Date | December 13, 2017 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
True Flow Valvuloplasty Perfusion Catheter
Dec 2017
Decision
78d
Days
Class 2
Risk
About This 510(k) Submission
K172932 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 December 13, 2017, 78 days after receiving the submission on September 26, 2017. 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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