Data / Medical devices / China / Dongguan TT Medical, Inc.
Dongguan TT Medical, Inc.: FDA-registered device maker in Dongguan Guangdong, China, 6 510(k) clearances
Dongguan TT Medical, Inc. is registered with the FDA (registration 3013152301) in Dongguan Guangdong, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013152301
- Address
- Bld# 1, 1 Taoyuan Road, Songshan Lake National High-Tech Industrial Park, Dongguan Guangdong, China, 523808
- Owner or operator
- Dongguan TT Medical, Inc. (10088168)
- Roles
- Manufacturer
- First device listed
- June 6, 2023
- Registered through
- 2026
- Brand names listed
- MultiStage, ValvuloPro, ValvuloPro Valvuloplasty Balloon Catheter, VesPenetrator, VesTraveler, VexPander
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Manufacturer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 2 | Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2026 | K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | OZT | Substantially Equivalent | Dongguan TT Medical, Inc. | accessdata.fda.gov |
| July 31, 2024 | K240967 | ValvuloPro Valvuloplasty Balloon Catheter | OZT | Substantially Equivalent | Dongguan TT Medical, Inc. | accessdata.fda.gov |
| October 12, 2023 | K231814 | ValvuloPro Valvuloplasty Balloon Catheter | OZT | Substantially Equivalent | Dongguan TT Medical, Inc. | accessdata.fda.gov |
| June 29, 2023 | K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | LOX | Substantially Equivalent | Dongguan TT Medical, Inc. | accessdata.fda.gov |
| March 9, 2023 | K222663 | MultiStage Balloon Dilatation Catheter | FGE | Substantially Equivalent | Dongguan TT Medical, Inc. | accessdata.fda.gov |
| March 1, 2023 | K222187 | Multistage Balloon Dilatation Catheter | KTI | Substantially Equivalent | Dongguan TT Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bronchoscope Accessory
- All makers of Balloon Aortic Valvuloplasty
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
Updated March 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.