# K001258: BX Transhepatic Biliary Stent and Delivery System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jun 27, 2000 after 70 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.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System (2001), 9 descendants of its own
- K012090: Cordis Palmaz Genesis Transhepatic Biliary Stent (2001), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K001258
Methodology: https://510kreport.com/methodology