# K040413: Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Europa, N.V.
- Decided: Jun 21, 2004 after 124 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: 6 generations back to K905720 (1991). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021345: Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System, Cordis Corp. (2002) Summary page 3.
- K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System, Cordis Europa, N.V. (2001) Summary page 3.
- K901406: Anatomic Modular Knee (Amk) Posterior Stabilized, Depuy, Inc. (1990) Summary page 3.
- K925072: Amk Landmark Revision Knee System, Depuy, Inc. (1994) Summary page 3.
- K933304: Anatomic Modular Knee (Amk) Posterior Stabilized, Depuy, Inc. (1993) Summary page 3.

## Most influential descendants
- K053454: RX Herculink Elite Biliary Stent System (2006), 1 descendant of its own
- K063481: Modification to RX Herculink Elite Biliary Stent System (2007), 0 descendants of its own

## Indications for use
The Cordis Palmaz® BLUETM .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K040413
Methodology: https://510kreport.com/methodology