# K024050: Cook Nephrostomy Dilation Balloon Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Feb 27, 2003 after 80 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) other Nephrostomy Dilation Balloons manufactured and marketed by Cook Urological: named in the summary without a submission number
- (no number) NephroMax Balloon Dilatation Catheter Sets marketed by Boston Scientific/Microvasive: named in the summary without a submission number

## Most influential descendants
- K171601: Ultraxx Nephrostomy Balloon Catheter (2018), 1 descendant of its own
- K172929: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (2018), 1 descendant of its own
- K213334: Monarch Platform, Urology (2022), 0 descendants of its own
- K181713: Ultraxx Nephrostomy Balloon Catheter Set (2018), 0 descendants of its own

## Recalls of this device
- Jan 27, 2016 · Class II · Z-1238-2016: Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has re
- Jan 27, 2016 · Class II · Z-1237-2016: Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has re

## Indications for use
The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used for one step, dilation of the musculofascial nephrostomy tract and placement of the working sheath.

Source page: https://510kreport.com/device/K024050
Methodology: https://510kreport.com/methodology