# K990867: RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Sep 2, 1999 after 170 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 K911581 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 1.

## Most influential descendants
- K993588: Modification to RX Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, (1999), 0 descendants of its own

## Indications for use
The RX Herculink™ 14 Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K990867
Methodology: https://510kreport.com/methodology