K241562
- 510(k) number
- K241562
- Device name
- OutFlo Aortic Valve Dilatation Balloon Catheter
- Applicant
- Disa Medinotec ZA
- Product code
- OZT — Balloon Aortic Valvuloplasty
- Decision date
- 2025-03-11
- Date received
- 2024-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241562.pdf
Official FDA record: K241562
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.