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Sign in to claim this brandTECHDEVICE CORPORATION
US
Last updated May 23, 2026
What TECHDEVICE CORPORATION makes
TechDevice Corporation manufactures manual guidewires for vascular and general-purpose use, including peripheral vascular and non-vascular applications. Their portfolio includes flexible guidewires designed for catheter insertion and navigation within blood vessels, supporting interventional procedures.
The company’s guidewires are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. TechDevice Corporation is based in 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 TechDevice Corporation manufacture?
TechDevice Corporation specializes in manual guidewires, which are used primarily for guiding catheters through blood vessels during medical procedures. Their devices include peripheral vascular guidewires (for blood vessels outside the heart) and general-purpose non-vascular guidewires (for non-blood vessel applications). These guidewires are designed to provide flexibility and precision for catheter insertion and navigation.
Where is TechDevice Corporation based?
TechDevice Corporation is headquartered in the United States. The company’s location is relevant for regulatory oversight, as it operates under U.S. medical device regulations, including those enforced by the FDA.
How are TechDevice Corporation’s devices classified under U.S. regulations?
TechDevice Corporation’s guidewires are classified as Class II medical devices under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory databases list TechDevice Corporation’s devices?
TechDevice Corporation’s devices are listed in the FDA’s 510(k) database, which tracks pre-market notifications for Class II devices, and the FDA’s Unique Device Identifier (UDI) database, which standardizes device labeling for tracking and traceability. These listings help healthcare providers and regulators identify and verify the devices.
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
- 088189175
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mermaid Medical® Guidewire | G60235150 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60335090 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60135180 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60135090 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60235180 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60135150 | FDA UDI | Class II | Active |
| ReShape Medical™ Guidewire | RSM300 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60235090 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60235260 | FDA UDI | Class II | Active |
| Mermaid Medical® Guidewire | G60135260 | FDA UDI | Class II | Active |
| Endologix Guidewire | K110241 | FDA 510(k) | Class II | Active |
| Techdevice Guidewire | K053028 | FDA 510(k) | Class II | Active |
| Techdevice Occlusion Balloon Catheter | K051137 | FDA 510(k) | Class II | Active |
| Techdevice Guidewire | K053251 | FDA 510(k) | Class II | Active |
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