# K011817: Bridge FX

- Pathway: 510(k) (Special)
- Applicant: Medtronic Ave, Inc.
- Decided: Aug 22, 2001 after 72 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: 2 generations back to K983008 (1998). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000744: Medtronic Ave Bridge X3 Stent, Medtronic Ave, Inc. (2000) Summary page 1.
- K992569: Medtronic Ave Bridge Stent, Medtronic Ave, Inc. (1999) Summary page 1.
- K993145: Medtronic Ave Bridge Stent, Medtronic Ave, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K052539: Cook Formula 418 Biliary Stent System (2005), 0 descendants of its own

## Indications for use
The Medtronic AVE Bridge™ FX Biliary Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.

Source page: https://510kreport.com/device/K011817
Methodology: https://510kreport.com/methodology