# K014205: Modification to Bridge Self-Expanding Biliary Stent Delivery System (Bridge SE)

- Pathway: 510(k) (Special)
- Applicant: Medtronic Ave, Inc.
- Decided: Jan 14, 2002 after 24 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: 1 generation back to K011080 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011080: Bridge SE Self-Expanding Stent Delivery System, Medtronic Ave, Inc. (2001) Summary page 1.

## Most influential descendants
- K022026: Medtronic Ave Bridge Polaris Biliary Stent System (Polaris) (2002), 1 descendant of its own
- K030839: Medtronic Ave Bridge Aurora Biliary Stent System (Aurora) (2003), 0 descendants of its own

## Indications for use
The Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K014205
Methodology: https://510kreport.com/methodology