Valvuloplasty Balloon Catheter (ValvuloPro)— 510(k) K260437

Name: FDA 510(k) clearance K260437
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Substantially Equivalent

Dongguan TT Medical, Inc.

FDA 510(k) clearance K260437 for Valvuloplasty Balloon Catheter (ValvuloPro), Substantially Equivalent on 2026-03-20. Applicant: Dongguan TT Medical, Inc.. Device class: 2.

Summary

Dongguan TT Medical's Valvuloplasty Balloon Catheter (ValvuloPro) is filed under OZT, balloon aortic valvuloplasty. The record doesn't list balloon sizes.

Class II, 21 CFR 870.1255. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Dongguan TT Medical filed from Dongguan, China. Review took 37 calendar days (February 11 to March 20, 2026).

Clearance details

Applicant: Dongguan TT Medical, Inc.
Product code: Product code OZT
Device class: Class 2
Regulation: 21 CFR 870.1255
Advisory panel: Cardiovascular
Date received: 2026-02-11
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

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K231814 — ValvuloPro Valvuloplasty Balloon Catheter2023-10-12
K220881 — INOUE BALLOON A2022-12-18

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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.