# K063532: Bard E Luminexx Biliary Stent

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: May 30, 2008 after 555 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020682 (2002). 2 ancestors in all.
6 later devices descend from it; 4 cite 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)
- K033497: Bard Luminexx 3 Biliary Stent and Delivery System, C.R. Bard, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K130792: Lifestent Biliary Stent System, Lifestent XL Biliary Stent System (2013), 0 descendants of its own
- K130591: Supera Veritas (2013), 0 descendants of its own

## Recalls of this device
- Dec 23, 2008 · Not classified · Z-1466-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1454-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1468-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1467-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1463-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1459-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1469-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1460-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1456-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1457-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1462-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1455-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1464-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1458-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1453-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1465-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula
- Dec 23, 2008 · Not classified · Z-1461-2009: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascula

## Indications for use
The proposed device is indicated for the treatment of biliary strictures resulting from malignant neoplasms.

Source page: https://510kreport.com/device/K063532
Methodology: https://510kreport.com/methodology