# K880167: Gore-Tex Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 18, 1988 after 120 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.
15 later devices descend from it; 2 cite it directly.
0 of 16 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
- K955460: Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular Graft (1996), 13 descendants of its own
- K960766: Meadox Medicals, Inc. Expanded Ptfe Vascular Graft (1997), 12 descendants of its own
- K962433: Meadox Exxcel Eptfe Vascular Graft (1997), 12 descendants of its own
- K052964: Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven (2006), 11 descendants of its own
- K071778: Hero Vascular Access Device (2008), 7 descendants of its own

Source page: https://510kreport.com/device/K880167
Methodology: https://510kreport.com/methodology