# K180919: GORE Tri-Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore and Associates, Inc.
- Decided: Oct 5, 2018 after 179 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: 2 generations back to K052257 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072618: Twin-Pass Otw Catheter, Model 5201, Vascular Solutions, Inc. (2007) Summary page 4.

## Indications for use
The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.

Source page: https://510kreport.com/device/K180919
Methodology: https://510kreport.com/methodology