# K172929: Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jan 10, 2018 after 107 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 K024050 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024050: Cook Nephrostomy Dilation Balloon Catheter Set, Cook Urological, Inc. (2003) Summary page 4.

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

## Indications for use
The Amplatz Type Renal Sheath is recommended for the establishment of percutaneous access. The Amplatz Type Renal Sheath Set is recommended for the establishment of percutaneous access. The Clear Renal Sheath is recommended for the establishment of percutaneous access.

Source page: https://510kreport.com/device/K172929
Methodology: https://510kreport.com/methodology