# K042985: Lifestent NT35 Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 23, 2004 after 55 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: 4 generations back to K010445 (2001). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024303: Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery System, Edwards Lifesciences, LLC (2003) Summary page 1.

## Most influential descendants
- K053404: Lifestent Flexstart Biliary Stent System (2005), 2 descendants of its own
- K060487: Lifestent Flexstar XL Biliary Stent System (2006), 1 descendant of its own
- K130792: Lifestent Biliary Stent System, Lifestent XL Biliary Stent System (2013), 0 descendants of its own

## Indications for use
The LifeStent NT35 Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree

Source page: https://510kreport.com/device/K042985
Methodology: https://510kreport.com/methodology