K260437

Substantially Equivalent

Valvuloplasty Balloon Catheter (ValvuloPro)

Applicant: Dongguan TT Medical, Inc.
Product code: OZT
Advisory panel: Cardiovascular
Date received: 2026-02-11
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Dongguan, CN

Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.