# K021824: Dynalink .035 Biliary Self-Expanding Stent System, Models 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jul 2, 2002 after 28 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014007: Dynalink .018 Billary Self-Expanding Stent System, Guidant Corp. (2002)

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

Source page: https://510kreport.com/device/K021824
Methodology: https://510kreport.com/methodology