# K183051: Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Jul 16, 2019 after 256 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 K924608 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915209: Malecot-Nephrostomy Tamponade Catheter, Cook Urological, Inc. (1992) Summary page 4.
- K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System, Boston Scientific Corp (2014) Summary page 4.

## Indications for use
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, ureteral drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures. The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.

Source page: https://510kreport.com/device/K183051
Methodology: https://510kreport.com/methodology