Modification to EPTFE Graft
FDA 510(k)Class II (US FDA 510(k))
by Vascutek Ltd
Identifiers
- 510(k) Number
- K041528 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)
This device is a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, made from expanded polytetrafluoroethylene (ePTFE) material. It is a synthetic graft used for vascular access or arterial bypass/reconstruction to restore or provide blood flow conduits.
It is implanted surgically by vascular surgeons in clinical settings. The device is supplied as a Class 2 cardiovascular device with product code DSY, cleared via the FDA 510(k) pathway under K041528, and is intended for use in accordance with its cleared indications.
Frequently asked questions
What is the MODIFICATION TO EPTFE GRAFT used for?
It is a synthetic graft made from expanded polytetrafluoroethylene (ePTFE) used for vascular access or arterial bypass/reconstruction to restore or provide blood flow conduits in vessels with a diameter of 6mm or greater.
How is the MODIFICATION TO EPTFE GRAFT supplied and implanted?
The device is supplied as a sterile prosthesis for single-use implantation and is surgically implanted by vascular surgeons in clinical settings to create blood flow conduits.
What regulatory pathway was used for the MODIFICATION TO EPTFE GRAFT?
It was cleared via the FDA 510(k) pathway under submission number K041528 as a Class 2 cardiovascular device with product code DSY, determined to be substantially equivalent to a predicate device.
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. Sources consulted: K041528 FDA 510 (k) - MODIFICATION TO EPTFE GRAFT, MODIFICATION TO EPTFE GRAFT (K041528) — FDA 510(k) | Innolitics, PDF K041528 MODIFICATION TO EPTFE GRAFT - 510kdatabase.net, K041528 FDA 510 (k) - MODIFICATION TO EPTFE GRAFT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041528 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascutek Ltd
- FDA Applicant
- Vascutek, Ltd.
Sources (1)
- FDA 510(k) K041528 24 fields · synced Oct 1, 2026