# K983075: Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Mar 3, 1999 after 182 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: 1 generation back to K905720 (1991). 2 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K905720: Palmaz Biliary Stent, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 1.

## Most influential descendants
- K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System (1999), 2 descendants of its own
- K060817: Omnilink. 018 Biliary Stent System (2006), 0 descendants of its own
- K053459: Omnilink .035 Biliary Stent System (2006), 0 descendants of its own
- K991032: Guidant Megalink Biliary Stent, Model FG1002949-58 (1999), 0 descendants of its own

## Indications for use
The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K983075
Methodology: https://510kreport.com/methodology