# K991032: Guidant Megalink Biliary Stent, Model FG1002949-58

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Apr 30, 1999 after 32 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 K905720 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983075: Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38, Guidant Corp. (1999) Summary page 1.

## 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/K991032
Methodology: https://510kreport.com/methodology