# K050627: Lifestent Turbo Biliary Stent Systems

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Mar 22, 2005 after 11 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: 2 generations back to K023248 (2003). 3 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023248: Lifestent LP SDS Biliary Endoprosthesis, Orbus Medical Technologies (2003) Summary page 1.
- K041370: Lifestent LP SDS Biliary Endoprosthesis, Orbus Medical Technologies (2004) Summary page 1.

## Most influential descendants
- K052149: Edwards Peripheral Dilation Catheter (2005), 47 descendants of its own
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own
- K122685: Angiosculpt Pta Scoring Balloon Catheter (2013), 28 descendants of its own

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

Source page: https://510kreport.com/device/K050627
Methodology: https://510kreport.com/methodology