# K050501: Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular Devices
- Decided: Mar 14, 2005 after 14 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: 4 generations back to K980823 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K050103: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Abbott Laboratories (2005) Summary page 1.

## Most influential descendants
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The Abbott Vascular DevicesTM Xceed TM Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K050501
Methodology: https://510kreport.com/methodology