K241562 is an FDA 510(k) clearance for the OutFlo Aortic Valve Dilatation Balloon Catheter. This device is classified as a Balloon Aortic Valvuloplasty (Class II - Special Controls, product code OZT).
Submitted by Disa Medinotec (Johannesburg, ZA). The FDA issued a Cleared decision on March 11, 2025, 284 days after receiving the submission on May 31, 2024.
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 | K241562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2024 |
| Decision Date | March 11, 2025 |
| Days to Decision | 284 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. |