K260437
- 510(k) number
- K260437
- Device name
- Valvuloplasty Balloon Catheter (ValvuloPro)
- Applicant
- Dongguan TT Medical, Inc. CN
- Product code
- OZT — Balloon Aortic Valvuloplasty
- Decision date
- 2026-03-20
- Date received
- 2026-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260437.pdf
Official FDA record: K260437
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.