# K013250: Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular Graft

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Oct 26, 2001 after 28 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) GORE-TEX® Stretch Vascular Grafts: named in the summary without a submission number

## Most influential descendants
- K202471: exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft (2020), 2 descendants of its own
- K221628: exGraft, exGraft Carbon (2022), 1 descendant of its own
- K233783: exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (2024), 0 descendants of its own

## Indications for use
GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, or for other vascular procedures.

Source page: https://510kreport.com/device/K013250
Methodology: https://510kreport.com/methodology