# K180182: Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 14, 2018 after 234 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K930483 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043581: Dual Lumen Catheter, Acmi Corporation (2005) Summary page 4.

## Indications for use
This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.

Source page: https://510kreport.com/device/K180182
Methodology: https://510kreport.com/methodology