K240967
- 510(k) number
- K240967
- Device name
- ValvuloPro Valvuloplasty Balloon Catheter
- Applicant
- Dongguan TT Medical, Inc. CN
- Product code
- OZT — Balloon Aortic Valvuloplasty
- Decision date
- 2024-07-31
- Date received
- 2024-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240967.pdf
Official FDA record: K240967
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.