# K903931: Gore-Tex (R) Stretch Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 6, 1990 after 104 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062161: Gore Propaten Vascular Graft (2006), 7 descendants of its own
- K130215: Gore Acuseal Vascular Graft (2013), 2 descendants of its own
- K232312: GORE® PROPATEN® Vascular Graft (2024), 1 descendant of its own
- K231505: GORE® ACUSEAL Vascular Graft (2023), 1 descendant of its own
- K240083: GORE® PROPATEN® Vascular Graft (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K903931
Methodology: https://510kreport.com/methodology