# K053454: RX Herculink Elite Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corporation
- Decided: Mar 6, 2006 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
Longest line of descent: 7 generations back to K905720 (1991). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010684: RX Herculink Plus Biliary Stent System, Guidant Corp. (2001) Summary page 1.
- K040413: Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System, Cordis Europa, N.V. (2004) Summary page 1.

## Most influential descendants
- K063481: Modification to RX Herculink Elite Biliary Stent System (2007), 0 descendants of its own

## Indications for use
The Guidant HERCULINK® ELITE Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K053454
Methodology: https://510kreport.com/methodology