# K181144: Angled Tip Ureteral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jun 28, 2018 after 58 days
- Product code: KOD (Catheter, Urological)
- 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: 4 generations back to K965229 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171600: Renal Access Cobra Catheter, Kumpe Access Catheter, Cook Incorporated (2018) Summary page 4.

## Indications for use
These devices are intended for access and catheterization of the urinary tract, including the following applications: • Delivery of contrast media • Navigation of a tortuous ureter • Access, advancement, or exchange of wire guides

Source page: https://510kreport.com/device/K181144
Methodology: https://510kreport.com/methodology