# K030633: Medtronic Ave Bridge Constant Biliary Stent System or ('Constant

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Ave, Inc.
- Decided: Sep 2, 2003 after 186 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 K983008 (1998). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991533: Medtronic Ave Stent Delivery System - for Use in Biliary Indication, Peripheral Ave (1999) Summary page 1.
- K011817: Bridge FX, Medtronic Ave, Inc. (2001)

## Most influential descendants
- 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 Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K030633
Methodology: https://510kreport.com/methodology