# K093893: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Traditional)
- Applicant: Idev Technologies, Inc.
- Decided: Oct 5, 2010 after 291 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: 7 generations back to K010445 (2001). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060557: Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060, Idev Technologies, Inc. (2006) Summary page 1.
- K071646: Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120, Idev Technologies, Inc. (2008) Summary page 1.
- K063532: Bard E Luminexx Biliary Stent, Bard Peripheral Vascular, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K130591: Supera Veritas (2013), 0 descendants of its own
- K111627: Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 0 descendants of its own

## Recalls of this device
- Jan 31, 2012 · Not classified · Z-1213-2012: The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length).

## Indications for use
SUPERA VERITAS TM 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/K093893
Methodology: https://510kreport.com/methodology