# K172588: Balloon Catheter and Balloon Ureteral Dilator Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 19, 2018 after 233 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- 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 K970041 (1997). 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)
- K970041: Ascend Balloon Dailation Catheter, Cook Urological, Inc. (1997) Summary page 4.

## Indications for use
The Balloon Ureteral Dilator and Balloon Ureteral Dilator Set is intended for ureteral dilation prior to ureteral stone manipulation or ureteroscopy and dilation of the intramural ureter.

Source page: https://510kreport.com/device/K172588
Methodology: https://510kreport.com/methodology