# K111627: Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Traditional)
- Applicant: Idev Technologies, Inc.
- Decided: Aug 21, 2012 after 438 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: 8 generations back to K010445 (2001). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093893: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, Idev Technologies, Inc. (2010) Summary page 1.
- K063532: Bard E Luminexx Biliary Stent, Bard Peripheral Vascular, Inc. (2008) Summary page 1.
- K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB, Cordis Corp. (2008) Summary page 1.
- K060057: Protege Everflex Self-Expanding Biliary Stent System, Ev3, Inc. (2006) Summary page 1.
- K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05, Ev3, Inc. (2008) Summary page 1.

## Indications for use
The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K111627
Methodology: https://510kreport.com/methodology