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Sign in to claim this brandWhat Dongguan TT Medical, Inc. makes
Dongguan TT Medical, Inc. manufactures coronary angioplasty balloon catheters for basic procedures, non-medicated dilation balloon catheters for gastrointestinal and biliary use, and bronchial balloon catheters. Their portfolio includes devices like the VexPander® for coronary interventions and the VesTraveler® for biliary applications, alongside MultiStage® catheters for cardiac valvuloplasty.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Dongguan TT Medical, Inc. manufacture?
Dongguan TT Medical, Inc. specializes in balloon catheters for specific medical procedures. Their primary products include coronary angioplasty balloon catheters for basic interventions, non-medicated dilation balloon catheters for gastrointestinal and biliary tract use, and bronchial balloon catheters for airway dilation. Examples of their devices are the VexPander® (used in coronary angioplasty), VesTraveler® (for biliary applications), and MultiStage® catheters (for cardiac valvuloplasty).
Where is Dongguan TT Medical, Inc. based?
Dongguan TT Medical, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support, particularly for markets that require domestic manufacturing or distribution.
Which regulatory registries or databases list Dongguan TT Medical, Inc.’s devices?
Dongguan TT Medical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the United States, ensuring transparency in the supply chain and aiding in post-market surveillance.
How are Dongguan TT Medical, Inc.’s devices classified under FDA regulations?
All of Dongguan TT Medical, Inc.’s listed devices fall under Class II classification by the FDA. This classification indicates that the devices pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
Why are Dongguan TT Medical, Inc.’s devices classified as Class II?
The Class II designation for these devices is based on their intended use and associated risks. For example, coronary angioplasty balloon catheters and valvuloplasty catheters involve direct vascular intervention, while gastrointestinal/biliary dilation catheters address high-risk anatomical areas prone to complications. The FDA requires additional controls for these devices to mitigate risks like perforation, thrombosis, or improper dilation, ensuring they meet strict performance and safety criteria before authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 551476865
Catalogue (233)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VexPander® | NC22530 | FDA UDI | Class II | Active |
| VexPander® | NC20030 | FDA UDI | Class II | Active |
| MultiStage® | MSO-1855-09 | FDA UDI | Class II | Active |
| VesTraveler® | SD37530 | FDA UDI | Class II | Active |
| VexPander® | NC30022 | FDA UDI | Class II | Active |
| VexPander® | NC27522 | FDA UDI | Class II | Active |
| MultiStage® | MSO-1230-09 | FDA UDI | Class II | Active |
| VesTraveler® | SD30038 | FDA UDI | Class II | Active |
| VexPander® | NC25010 | FDA UDI | Class II | Active |
| VexPander® | NC37534 | FDA UDI | Class II | Active |
| VesPenetrator® | PD15010 | FDA UDI | Class II | Active |
| VesTraveler® | SD30030 | FDA UDI | Class II | Active |
| VexPander® | NC27530 | FDA UDI | Class II | Active |
| VexPander® | NC40030 | FDA UDI | Class II | Active |
| ValvuloPro® | VBC1540 | FDA UDI | Class II | Active |
| MultiStage® | MSO-1030-08 | FDA UDI | Class II | Active |
| VexPander® | NC20022 | FDA UDI | Class II | Active |
| VesTraveler® | SD32526 | FDA UDI | Class II | Active |
| MultiStage® | MSO-0855-09 | FDA UDI | Class II | Active |
| MultiStage® | MSW-0830-17 | FDA UDI | Class II | Active |
| ValvuloPro® | VBC2640 | FDA UDI | Class II | Active |
| MultiStage® | MSO-1830-17 | FDA UDI | Class II | Active |
| VexPander® | NC37530 | FDA UDI | Class II | Active |
| VesPenetrator® | PD17526 | FDA UDI | Class II | Active |
| VesTraveler® | SD32534 | FDA UDI | Class II | Active |
| MultiStage® | MSW-0855-09 | FDA UDI | Class II | Active |
| VesTraveler® | SD40030 | FDA UDI | Class II | Active |
| VexPander® | NC32514 | EUDAMEDFDA UDI | Class II | Active |
| VesTraveler® | SD25038 | FDA UDI | Class II | Active |
| MultiStage® | MSO-0630-23 | FDA UDI | Class II | Active |
| VesTraveler® | SD20010 | FDA UDI | Class II | Active |
| MultiStage® | MSO-0855-08 | FDA UDI | Class II | Active |
| VesPenetrator® | PD15014 | FDA UDI | Class II | Active |
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