# K974541: Modified Ureteral Indwelling Catheter/Stent

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 9, 1998 after 68 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K163399: Tria Firm Ureteral Stent (2017), 3 descendants of its own
- K190603: Tria Firm Ureteral Stent (2019), 2 descendants of its own
- K250824: Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (2025), 0 descendants of its own
- K191609: Tria Soft Ureteral Stent (2019), 0 descendants of its own

## Recalls of this device
- Nov 16, 2020 · Class II · Z-0758-2021: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
- Nov 16, 2020 · Class II · Z-0757-2021: Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

## Indications for use
The Modified Ureteral Stent is intended to facilitate drainage from the kidney to the bladder via placement transurethrally, percutaneously, or via open surgery by a trained physician.

Source page: https://510kreport.com/device/K974541
Methodology: https://510kreport.com/methodology