# K130215: Gore Acuseal Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Apr 9, 2013 after 70 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). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
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.
- K903931: Gore-Tex (R) Stretch Vascular Graft, W. L. Gore & Associates, Inc. (1990) Summary page 2.
- K030999: Eptfe Vascular Prosthesis; Sealptfe, Vascutek, Ltd. (2003) Summary page 2.

## Most influential descendants
- K231505: GORE® ACUSEAL Vascular Graft (2023), 1 descendant of its own
- K233551: GORE® ACUSEAL Vascular Graft (2023), 0 descendants of its own

## Indications for use
The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

Source page: https://510kreport.com/device/K130215
Methodology: https://510kreport.com/methodology