# K062161: Gore Propaten Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 9, 2006 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830806 (1983). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830806: Vascular Graft/Bifurcated/Fep-Ringed, W. L. Gore & Associates, Inc. (1983) Summary page 2.
- K903931: Gore-Tex (R) Stretch Vascular Graft, W. L. Gore & Associates, Inc. (1990) Summary page 2.
- K933943: Fep Ringed Gore-Tex Stretch Vascualr Graft with Removable Rings, W. L. Gore & Associates, Inc. (1993) Summary page 2.

## Most influential descendants
- 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
- K233551: GORE® ACUSEAL Vascular Graft (2023), 0 descendants of its own

## Recalls of this device
- May 12, 2021 · Class II · Z-2292-2021: Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
- May 12, 2021 · Class II · Z-2293-2021: Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.

## Indications for use
GORE PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis 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/K062161
Methodology: https://510kreport.com/methodology