# K024303: Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 3, 2003 after 191 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 K010445 (2001). 6 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K001843: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2000) Summary page 1.
- K010445: Precise Nitinol Stent Transhepatic Billary System, Cordis Corp. (2001) Summary page 1.
- K012993: Modification to Precise Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2001) Summary page 1.
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2002) Summary page 1.

## Most influential descendants
- K042985: Lifestent NT35 Biliary Stent System (2004), 3 descendants of its own
- 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 Edwards Lifesciences LifeStent NTl8 Self-Expanding Biliary Stent and Delivery System is indicated for use in the palliative treatment of patients with malignant biliary strictures.

Source page: https://510kreport.com/device/K024303
Methodology: https://510kreport.com/methodology