Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers
FDA 510(k)Class II (US FDA 510(k))
by Vascutek Ltd
Identifiers
- 510(k) Number
- K060142 FDA 510(k)
- FDA Product Code
- DSY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3450 FDA 510(k)
- Regulation Number
- 870.3450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers is a vascular graft prosthesis with a diameter of 6mm or greater. It is designed for use in cardiovascular procedures as a replacement or bypass vessel.
This device is supplied as a sterile, single-use product and is not intended for reuse. It is available in various sizes and includes radiopaque markers for visibility during procedures. The device has received FDA 510(k) clearance with the product code DSY.
Frequently asked questions
What is the Vascutek Gelweave Siena Collared Anteflo and Plexus used for?
This vascular graft prosthesis is designed for use in cardiovascular procedures as a replacement or bypass vessel with a diameter of 6mm or greater. It includes radiopaque markers for enhanced visibility during procedures.
How is the Vascutek Gelweave Siena Collared Anteflo supplied?
The device is supplied as a sterile, single-use product and is not intended for reuse. It is available in various sizes to accommodate different clinical requirements.
What is the regulatory status of this vascular graft?
The Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque Markers has received FDA 510(k) clearance with the product code DSY. It is classified as a Class II device for cardiovascular procedures.
Are there different sizes available for this vascular graft?
Yes, the Vascutek Gelweave Siena Collared Anteflo and Plexus is available in various sizes with a diameter of 6mm or greater to accommodate different clinical needs and anatomical considerations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060142 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascutek Ltd
- FDA Applicant
- Vascutek, Ltd.
Sources (1)
- FDA 510(k) K060142 24 fields · synced Sep 23, 2026