# K033497: Bard Luminexx 3 Biliary Stent and Delivery System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 4, 2004 after 91 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: 1 generation back to K020682 (2002). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020682: Bard Luminexx 6 FR Biliary Stent and Delivery System, C.R. Bard, Inc. (2002) Summary page 1.

## Most influential descendants
- K063532: Bard E Luminexx Biliary Stent (2008), 6 descendants of its own
- K093893: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2010), 4 descendants of its own
- K111766: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems (2011), 2 descendants of its own
- K122546: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 1 descendant of its own
- K082093: Bullseye Biliary Stent System (2009), 1 descendant of its own

## Recalls of this device
- Jul 21, 2005 · Not classified · Z-1585-05: Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause t

## Indications for use
The Bard® LUMINEXX TM 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Source page: https://510kreport.com/device/K033497
Methodology: https://510kreport.com/methodology