# K993145: Medtronic Ave Bridge Stent

- Pathway: 510(k) (Special)
- Applicant: Medtronic Ave, Inc.
- Decided: Oct 21, 1999 after 31 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.
6 later devices descend from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K011817: Bridge FX (2001), 5 descendants of its own
- K030633: Medtronic Ave Bridge Constant Biliary Stent System or ('Constant (2003), 2 descendants of its own
- K051785: Formula 418 Biliary Stent (2005), 1 descendant 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

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

Source page: https://510kreport.com/device/K993145
Methodology: https://510kreport.com/methodology