# K232312: GORE® PROPATEN® Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jan 9, 2024 after 160 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
Longest line of descent: 2 generations back to K830806 (1983). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062161: Gore Propaten Vascular Graft, W. L. Gore & Associates, Inc. (2006) Summary page 4.

## Most influential descendants
- K240083: GORE® PROPATEN® Vascular Graft (2024), 0 descendants of its own

## Indications for use
GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Source page: https://510kreport.com/device/K232312
Methodology: https://510kreport.com/methodology