# K080360: Endologix Visiflex Dual Lumen Catheter

- Pathway: 510(k) (Special)
- Applicant: Endologix, Inc.
- Decided: Apr 8, 2008 after 57 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: 1 generation back to K991601 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991601: Dual Lumen Catheter, Model DL-35-90, Endologix, Inc. (1999) Summary page 1.

## Indications for use
For use during a two guidewire procedure

Source page: https://510kreport.com/device/K080360
Methodology: https://510kreport.com/methodology