# K260437: Valvuloplasty Balloon Catheter (ValvuloPro)

- Pathway: 510(k) (Special)
- Applicant: Dongguan TT Medical, Inc.
- Decided: Mar 20, 2026 after 37 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K240967 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240967: ValvuloPro Valvuloplasty Balloon Catheter, Dongguan TT Medical, Inc. (2024) Summary page 5.

## Indications for use
The ValvuloPro Valvuloplasty Balloon Catheter is indicated for balloon aortic vavuloplasty.

Source page: https://510kreport.com/device/K260437
Methodology: https://510kreport.com/methodology