# Dongguan TT Medical, Inc.

- Location (FDA's records): Dongguan, CN
- FDA decisions: 6 (2023–2026): 6 510(k) clearances
- Product codes: OZT (3), KTI (1), FGE (1), LOX (1)
- 510(k) review time since 2016: median 188 days, against 168 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Orbusneich Medical, Inc.: 1 (https://510kreport.com/company/orbusneich-medical)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)

## Its most-cited devices
- K240967: ValvuloPro Valvuloplasty Balloon Catheter (2024), cited by 1

## Recent decisions
- K260437: Valvuloplasty Balloon Catheter (ValvuloPro) (Mar 20, 2026)
- K240967: ValvuloPro Valvuloplasty Balloon Catheter (Jul 31, 2024)
- K231814: ValvuloPro Valvuloplasty Balloon Catheter (Oct 12, 2023)
- K230374: Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) (Jun 29, 2023)
- K222663: MultiStage Balloon Dilatation Catheter (Mar 9, 2023)
- K222187: Multistage Balloon Dilatation Catheter (Mar 1, 2023)

Source page: https://510kreport.com/company/dongguan-tt-medical