# K041962: Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 1, 2004 after 72 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: 8 generations back to K905720 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033909: Wavemax Balloon-Expandable Transhepatic Biliary Stent System, Abbott Laboratories (2004) Summary page 1.

## Indications for use
The Abbott Vascular Devices XpandTM Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K041962
Methodology: https://510kreport.com/methodology