# K130792: Lifestent Biliary Stent System, Lifestent XL Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 30, 2013 after 161 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010445 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053404: Lifestent Flexstart Biliary Stent System, Edwards Lifesciences, LLC (2005) Summary page 1.
- K060487: Lifestent Flexstar XL Biliary Stent System, Edwards Lifesciences, LLC (2006) Summary page 1.
- K063532: Bard E Luminexx Biliary Stent, Bard Peripheral Vascular, Inc. (2008) Summary page 1.

## Indications for use
The LifeStent / XL Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K130792
Methodology: https://510kreport.com/methodology