# K991602: Eptfe Ringed Gore-Tex Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jul 9, 1999 after 60 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GORE-TEX Vascular Grafts: named in the summary without a submission number
- (no number) IMPRA Flex PTFE Vascular Graft: named in the summary without a submission number
- (no number) Atrium Hybrid Vascular Graft: named in the summary without a submission number

## Indications for use
The ePTFE Ringed GORE-TEX Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in the patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Source page: https://510kreport.com/device/K991602
Methodology: https://510kreport.com/methodology