# K093934: Gore Hybrid Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W.L. Gore & Associates
- Decided: Mar 17, 2010 after 85 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 2.
- K013648: Viabahn Endoprosthesis, W. L. Gore & Associates, Inc. (2002) Summary page 2.
- K071923: Ptfe Flixene Graduated Wall Graft, Atrium Medical Corp. (2007) Summary page 2.
- K051332: Advanta T-Graft, Atrium Medical Corp. (2005) Summary page 2.

## Indications for use
The GORE HYBRID Vascular Graft is indicated 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/K093934
Methodology: https://510kreport.com/methodology