Gore-Tex Vascular Graft, FEP-Ringed
by W. L. Gore & Associates, Inc.
510(k) K842144
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842144 | Date1 Oct 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DYF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Gore-Tex Vascular Graft, FEP-Ringed is classified as a Prosthesis, Vascular Graft, of less than 6 mm diameter. It is a synthetic vascular graft designed to replace or bypass damaged blood vessels, facilitating blood flow in cardiovascular procedures. Constructed with expanded polytetrafluoroethylene (ePTFE), this graft provides a durable, biocompatible conduit for arterial reconstruction.
This device is supplied sterile and intended for single-use in vascular bypass procedures, including axillobifemoral applications. It is available in multiple configurations, including straight and tapered designs, and is reinforced with removable FEP (fluorinated ethylene propylene) rings to aid in deployment and stability. The graft is regulated under FDA 510(k) clearance (K842144) and falls under Class II medical device classification (DYF). Storage and handling must comply with sterile medical device protocols.
Other devices from W. L. Gore & Associates, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Gore-Tex Vascular Graft, FEP-Ringed intended for?
The Gore-Tex Vascular Graft, FEP-Ringed is a synthetic vascular graft designed to replace or bypass damaged blood vessels, facilitating blood flow in cardiovascular procedures such as axillobifemoral bypass. It is constructed from expanded polytetrafluoroethylene (ePTFE) and is intended for use in arterial reconstruction where a durable, biocompatible conduit is needed.
How is the Gore-Tex Vascular Graft, FEP-Ringed supplied and is it reusable?
The device is supplied sterile and intended for single-use only. It must not be reprocessed or reused, as doing so could compromise sterility, structural integrity, and patient safety. Each graft is designed for one-time implantation during a vascular bypass procedure.
What sizes and configurations are available for the Gore-Tex Vascular Graft, FEP-Ringed?
The graft is available in multiple configurations, including straight and tapered designs, and is reinforced with removable FEP (fluorinated ethylene propylene) rings to aid in deployment and stability. It is classified as a prosthesis for vascular grafts of less than 6 mm diameter, though specific inner diameters and lengths are not detailed in the provided data.
What regulatory pathway was used for the Gore-Tex Vascular Graft, FEP-Ringed?
The device was cleared through the FDA 510(k) process under submission K842144, with a decision date of October 1, 1984. It is classified as a Class II medical device under product code DYF and regulation number 870.3450, and was found substantially equivalent to a predicate device.
How should the Gore-Tex Vascular Graft, FEP-Ringed be stored and handled?
The graft must be stored and handled in accordance with sterile medical device protocols to maintain its sterility and integrity until use. It is supplied sterile, so storage conditions should prevent damage to the packaging and preserve the sterile barrier until the point of implantation.