# K002143: Dynalink Biliary Self-Expanding Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Oct 12, 2000 after 87 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030053: Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 (2003), 8 descendants of its own
- K033537: Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005 (2003), 7 descendants of its own
- K011881: Dynalink .035 Biliary Self-Expanding Stent System (2001), 5 descendants of its own
- K014184: Modification to Dynalink .035 Biliary Self-Expanding Stent System (2002), 4 descendants of its own
- K033393: Absolute .035 Self-Expanding Biliary Stent System (2003), 3 descendants of its own

Source page: https://510kreport.com/device/K002143
Methodology: https://510kreport.com/methodology