# K991533: Medtronic Ave Stent Delivery System - for Use in Biliary Indication

- Pathway: 510(k) (Traditional)
- Applicant: Peripheral Ave
- Decided: Jul 29, 1999 after 87 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Peripheral AVE Stent Delivery System - For Use In Biliary Indication: named in the summary without a submission number

## Most influential descendants
- K030633: Medtronic Ave Bridge Constant Biliary Stent System or ('Constant (2003), 2 descendants of its own
- K032768: Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L) (2003), 1 descendant of its own
- K092352: Scuba Biliary Stent System (2010), 0 descendants of its own
- K061235: Lifestent Turbo Biliary Stent System (2006), 0 descendants of its own

## Indications for use
The Medtronic AVE Bridge™ Stent System — Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor

Source page: https://510kreport.com/device/K991533
Methodology: https://510kreport.com/methodology