# K021345: Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jun 28, 2002 after 60 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018” Delivery System: named in the summary without a submission number

## Most influential descendants
- 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
- K051785: Formula 418 Biliary Stent (2005), 1 descendant of its own
- K063481: Modification to RX Herculink Elite Biliary Stent System (2007), 0 descendants of its own
- K052539: Cook Formula 418 Biliary Stent System (2005), 0 descendants of its own

## Indications for use
The Cordis PALMAZ@ GENESISTMTranshepatic Biliary Stent on SLALOMTM .018” Delivery System is intended for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K021345
Methodology: https://510kreport.com/methodology