# K172527: Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Oct 19, 2017 after 59 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: 1 generation back to K820865 (1982). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851144: Ureteral Dilation Set, Van-Tec, Inc. (1985) Summary page 9.
- K820865: Van-Tec Fascial Dilator, Van-Tec, Inc. (1982) Summary page 9.

## Most influential descendants
- K213334: Monarch Platform, Urology (2022), 0 descendants of its own

## Indications for use
Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath. Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract. Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath. Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement of a sheath. Amplatz Radiopaque TFE Sheath is intended to be used as a working channel to maintain a previously established nephrostomy tract. Clear Amplatz Sheath with Radiopaque Stripe is intended to be used as a working channel to maintain a previously established nephrostomy tract.

Source page: https://510kreport.com/device/K172527
Methodology: https://510kreport.com/methodology