Data / Medical devices / United States / TT Medical Usa, LLC
TT Medical Usa, LLC: FDA-registered device maker in Duxbury, MA, United States, 1 510(k) clearance
TT Medical Usa, LLC is registered with the FDA (registration 3030421123) in Duxbury, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030421123
- Address
- 62 Strawberry Ln, Duxbury, MA, United States, 02332
- Owner or operator
- TT Medical USA, LLC (10090008)
- Roles
- Specification developer
- First device listed
- December 10, 2025
- Registered through
- 2026
- Brand names listed
- VesPenetrator, VesTraveler, VexPander
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
Updated June 29, 2023. 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.