# K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System

- Pathway: 510(k) (Special)
- Applicant: Cordis Europa, N.V.
- Decided: Aug 1, 2001 after 30 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: 5 generations back to K905720 (1991). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001258: BX Transhepatic Biliary Stent and Delivery System, Cordis Corp. (2000) Summary page 1.
- K992755: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube, Cordis, A Johnson & Johnson Co. (1999) Summary page 1.
- K994156: Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B, Cordis Corp. (2000) Summary page 1.
- K003159: Cordis Slalom Pta Balloon Catheter, Cordis Corp. (2000) Summary page 2.

## Most influential descendants
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System (2001), 5 descendants of its own
- K040413: Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System (2004), 2 descendants of its own
- K053454: RX Herculink Elite Biliary Stent System (2006), 1 descendant of its own
- K033909: Wavemax Balloon-Expandable Transhepatic Biliary Stent System (2004), 1 descendant of its own
- K033394: Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System (2003), 1 descendant of its own

## Indications for use
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .01 8” Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K012056
Methodology: https://510kreport.com/methodology