# K032768: Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)

- Pathway: 510(k) (Special)
- Applicant: Medtronic Ave, Inc.
- Decided: Oct 9, 2003 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983008 (1998). 7 ancestors in all.
1 later device descends 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)
- K030633: Medtronic Ave Bridge Constant Biliary Stent System or ('Constant, Medtronic Ave, Inc. (2003) Summary page 1.

## Most influential descendants
- K092352: Scuba Biliary Stent System (2010), 0 descendants of its own

## Recalls of this device
- Jul 30, 2009 · Not classified · Z-1802-2010: Mislabeling-- The incorrect Instructions for use may have been included with this product.

## Indications for use
The Medtronic, Inc. RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K032768
Methodology: https://510kreport.com/methodology