# K030839: Medtronic Ave Bridge Aurora Biliary Stent System (Aurora)

- Pathway: 510(k) (Special)
- Applicant: Medtronic Ave, Inc.
- Decided: May 30, 2003 after 74 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: 3 generations back to K011080 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022026: Medtronic Ave Bridge Polaris Biliary Stent System (Polaris), Medtronic Ave, Inc. (2002) Summary page 1.

## Indications for use
The Aurora Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K030839
Methodology: https://510kreport.com/methodology