# K992318: Medtronic Ave Bridge Stent

- Pathway: 510(k) (Special)
- Applicant: Medtronic Ave, Inc.
- Decided: Aug 2, 1999 after 21 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 K983008 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983008: Peripheral Ave Stent System, Peripheral Ave (1998) Summary page 3.
- (no number) Peripheral AVE Stent Delivery System - For Use In Biliary Indication: named in the summary without a submission number

## Indications for use
The Medtronic AVE Bridge™ Stent System (Hi-Flex) — Biliary Indication is intended to maintain patency of a bile duct which is occluded by a malignant tumor.

Source page: https://510kreport.com/device/K992318
Methodology: https://510kreport.com/methodology