K231814
- 510(k) number
- K231814
- Device name
- ValvuloPro Valvuloplasty Balloon Catheter
- Applicant
- Dongguan TT Medical, Inc. CN
- Product code
- OZT — Balloon Aortic Valvuloplasty
- Decision date
- 2023-10-12
- Date received
- 2023-06-21
- 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: K231814.pdf
Official FDA record: K231814
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.