# K201165: In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Dec 17, 2020 after 230 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: 3 generations back to K051316 (2005). 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)
- K080944: X-Force Nephrostomy Balloon Dilation Catheter, C.R. Bard, Inc. (2008) Summary page 4.

## Indications for use
The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the duration of the percutaneous tract dilation). The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).

Source page: https://510kreport.com/device/K201165
Methodology: https://510kreport.com/methodology