# K014184: Modification to Dynalink .035 Biliary Self-Expanding Stent System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jan 18, 2002 after 29 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 K002143 (2000). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011881: Dynalink .035 Biliary Self-Expanding Stent System, Guidant Corp. (2001) Summary page 1.

## Most influential descendants
- K033393: Absolute .035 Self-Expanding Biliary Stent System (2003), 3 descendants of its own
- K072720: Alimaxx-B Uncovered Biliary Stent System (2008), 1 descendant of its own
- K093947: Alimaxx-B Uncovered Biliary Stent System Endoscopic (2010), 0 descendants of its own
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K014184
Methodology: https://510kreport.com/methodology