# K171601: Ultraxx Nephrostomy Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 23, 2018 after 267 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- 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 K952968 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K121614: Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter, Boston Scientific Corp (2012) Summary page 4.
- K024050: Cook Nephrostomy Dilation Balloon Catheter Set, Cook Urological, Inc. (2003) Summary page 5.

## Most influential descendants
- K181713: Ultraxx Nephrostomy Balloon Catheter Set (2018), 0 descendants of its own

## Indications for use
The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

Source page: https://510kreport.com/device/K171601
Methodology: https://510kreport.com/methodology