# K052132: Modification to: Lifestent Valeo Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 24, 2005 after 19 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: 3 generations back to K941706 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023308: Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 1.
- K033212: Lifestent SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 1.
- K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis, Orbus Medical Technologies (2004) Summary page 1.
- K041032: Modification to Lifestent SDS and XL SDS Biliary Endoprosthesis, Orbus Medical Technologies (2004) Summary page 1.
- K050627: Lifestent Turbo Biliary Stent Systems, Edwards Lifesciences, LLC (2005) Summary page 1.

## Indications for use
The Edwards Lifesciences LifeStent Valeo Biliary Stent Systems are indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K052132
Methodology: https://510kreport.com/methodology