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Sign in to claim this brandVascular Graft Solutions, Ltd.
US
Last updated May 30, 2026
What Vascular Graft Solutions, Ltd. makes
Vascular Graft Solutions, Ltd. manufactures intravascular anastomosis occluders, including the VIOLA device, designed to seal or occlude blood vessels during surgical procedures. These products are intended for use in vascular interventions where precise vessel closure is required.
The company’s portfolio is regulated under FDA Class II devices and is listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. The manufacturer 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 Vascular Graft Solutions, Ltd. manufacture?
Vascular Graft Solutions, Ltd. specializes in intravascular anastomosis occluders, such as the VIOLA device. These devices are designed to seal or occlude blood vessels during surgical procedures, ensuring precise vessel closure in vascular interventions.
Where is Vascular Graft Solutions, Ltd. based?
The company is headquartered in the United States. This location influences its regulatory compliance and reporting requirements under U.S. medical device regulations.
Which regulatory registries list devices manufactured by Vascular Graft Solutions, Ltd.?
Devices from Vascular Graft Solutions, Ltd. are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identification (UDI) system. These registries track Class II devices like occluders to ensure traceability and compliance with U.S. medical device regulations.
How are the devices produced by Vascular Graft Solutions, Ltd. classified under FDA regulations?
All devices manufactured by Vascular Graft Solutions, Ltd., including the VIOLA occluder, fall under FDA Class II classification. This classification indicates moderate risk and requires specific controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- graftsolutions.com
- —
- —
- [email protected]
- Phone
- +97235499054
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 532829384
Catalogue (4)
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Vascular Graft Solutions Tel Aviv · IL FEI 3010652124