# K231814: ValvuloPro Valvuloplasty Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan TT Medical, Inc.
- Decided: Oct 12, 2023 after 113 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: 2 generations back to K122012 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140241: Edwards Transfemoral Balloon Catheter, Edwards Lifesciences, LLC (2014) Summary page 5.

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

Source page: https://510kreport.com/device/K231814
Methodology: https://510kreport.com/methodology