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Sign in to claim this brandVASCUTEK LTD
US
Last updated May 24, 2026
What VASCUTEK LTD makes
Vascutek Ltd manufactures synthetic vascular grafts, including textured and reinforced prostheses for arterial and venous applications, as well as animal-derived cardiovascular patches for surgical repair. Their product line includes devices like the Gelweave Vascular Prostheses and the Thoraflex Hybrid, designed for use in cardiovascular procedures such as bypass surgeries and aortic repairs. Additional offerings include Gelweave and Gelsoft Plus variants, tailored for specific vascular reconstruction needs.
The company’s devices are regulated under FDA’s Class II and Class III classifications, with products listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use in the United States, adhering to applicable medical device regulations. Vascutek Ltd is headquartered in the US.
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 Vascutek Ltd manufacture?
Vascutek Ltd specializes in vascular medical devices, primarily synthetic vascular grafts and animal-derived cardiovascular patches. Their synthetic grafts, such as the Gelweave Vascular Prostheses, are designed for arterial and venous applications, often used in bypass surgeries. Additionally, they produce cardiovascular patches like the Thoraflex Hybrid, which are used for surgical repairs in the cardiovascular system. These devices are tailored for procedures requiring durable vascular reconstruction.
Where is Vascutek Ltd based, and where are their devices primarily used?
Vascutek Ltd is headquartered in the United States. Their devices are manufactured and intended for use in the US market, adhering to applicable medical device regulations in that region. The company’s focus on vascular grafts and patches aligns with surgical needs within the US healthcare system.
Which regulatory registries or databases list Vascutek Ltd’s devices?
Vascutek Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Vascutek Ltd’s devices classified under medical device regulations?
Vascutek Ltd’s devices fall under FDA’s Class II and Class III classifications. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval due to insufficient data through other means. The classification depends on the device’s intended use and potential health impact, such as the complexity of vascular grafts or patches.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- terumomedical.com
- —
- —
- [email protected]
- Phone
- +1(800)888-3786
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 229053087
Catalogue (2520)
Page 50 of 51| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Maxiflo™ | S1007 | FDA UDI | Class II | Unknown |
| SealPTFE™ | S6006S | FDA UDI | Class II | Unknown |
| Thinwall | 921575T | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631608P50 | FDA UDI | Class II | Active |
| Gelsoft™ Cardiovascular Patch | 961204 | FDA UDI | Class II | Active |
| Gelweave™ | 7325243BL | FDA UDI | Class II | Active |
| Maxiflo™ | T3007 | FDA UDI | Class II | Unknown |
| Gelweave Vascular Prostheses | 730030ADPE | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 73241088/10E | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 73241488/8ARME | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 73241088/10RME | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 730022ADPE | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 732028CX4RME | FDA UDI | Class II | Active |
| Gelweave™ | 732012810/10STD | FDA UDI | Class II | Active |
| Gelweave™ | 732028/8 | FDA UDI | Class II | Active |
| Vp1200k™ | 321407 | FDA UDI | Class II | Unknown |
| Gelweave Vascular Prostheses | 732010108/8RME | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 732026CX4E | FDA UDI | Class II | Active |
| Gelsoft Plus Vascular Prostheses | 636012PE | FDA UDI | Class II | Active |
| Thoraflex™ Hybrid | THP2224X100A | FDA UDI | Class III | Active |
| Thoraflex™ Hybrid | THA3036X100B | FDA UDI | Class III | Active |
| Maxiflo™ | S50S10 | FDA UDI | Class II | Unknown |
| Gelweave™ | 73241088/10SA | FDA UDI | Class II | Active |
| Gelweave™ | 7320128/10RME | FDA UDI | Class II | Active |
| Maxiflo™ | S4005E | FDA UDI | Class II | Unknown |
| Maxiflo™ | T3005 | FDA UDI | Class II | Unknown |
| Maxiflo™ | W30ST0406 | FDA UDI | Class II | Unknown |
| Gelweave Vascular Prostheses | 734024/10ADP20E | FDA UDI | Class II | Active |
| Gelweave Vascular Prostheses | 736006E | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631006P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631206P50 | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 633012P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631206P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 633006P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 636012P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 635022P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 691008BP | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631512P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631809PCOL2 | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 690807BP | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 631407P50 | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 632211P | FDA UDI | Class II | Active |
| Gelsoft Plus™ | 690807AP | FDA UDI | Class II | Active |
| Maxiflo, Taperflo | K092863 | FDA 510(k) | Class II | Active |
| Gelsoft™ Plus Vascular Prostheses | K241070 | FDA 510(k) | Class II | Active |
| Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | K200955 | FDA 510(k) | Class II | Active |
| Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | K162803 | FDA 510(k) | Class II | Active |
| Vascutek Gelsoft Plus Vascular Graft | K955230 | FDA 510(k) | Class II | Active |
| Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | K963611 | FDA 510(k) | Class II | Active |
| Vascutek Ptfe Supported Eptfe Vascular Prostheses | K043552 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Vascutek Ltd. Inchinnan Renfrewshire · GB FEI 3002808437