# K191446: Ureteral Stent Systems, Biliary Drainage Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jan 2, 2020 after 216 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K944290 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023870: Flexima Biliary Catheter, Boston Scientific/Medi-Tech (2002) Summary page 7.
- K944290: Catheters, Biliary Catheters, Urological, Boston Scientific Corp (1994) Summary page 7.

## Indications for use
The Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The Flexima™ Biliary Catheter System / Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker are intended to provide external and internal percutaneous drainage of the biliary system.

Source page: https://510kreport.com/device/K191446
Methodology: https://510kreport.com/methodology