# K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Sep 4, 2003 after 24 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: 4 generations back to K010445 (2001). 9 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2002)
- K031777: Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2003)

## Most influential descendants
- K060557: Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060 (2006), 6 descendants of its own
- K071646: Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120 (2008), 5 descendants of its own
- K093893: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2010), 4 descendants of its own
- K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (2008), 4 descendants of its own
- K111766: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems (2011), 2 descendants of its own

## Indications for use
The Cordis S.M.A.R.T.TMControlTMNitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K032457
Methodology: https://510kreport.com/methodology