# K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Sep 7, 2001 after 28 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). 13 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K012090: Cordis Palmaz Genesis Transhepatic Biliary Stent, Cordis, A Johnson & Johnson Co. (2001)
- K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System, Cordis Europa, N.V. (2001) Summary page 1.
- K971448: Cordis Opta LP Pta Balloon Catheter, Cordis Corp. (1997) Summary page 1.
- K981407: Opta LP Pta Balloon Catheter/Powerflex Plus Pta Balloon Catheter, Cordis Corp. (1998) Summary page 1.
- K991028: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories, Cordis Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- K092352: Scuba Biliary Stent System (2010), 0 descendants of its own
- K041962: Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605 (2004), 0 descendants of its own
- K020809: Modification to Cordis Palmaz Genesis Transhepatic Biliary Stent (2002), 0 descendants of its own

## Indications for use
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA™ PRO .035” Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K012590
Methodology: https://510kreport.com/methodology