# K250410: GORE® Tri-Lobe Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jun 2, 2025 after 109 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003495 (2001). 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)
- K081799: Gore Tri-Lobe Balloon Catheter, W. L. Gore & Associates, Inc. (2008) Summary page 5.

## Indications for use
The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Source page: https://510kreport.com/device/K250410
Methodology: https://510kreport.com/methodology