# K031777: Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jul 7, 2003 after 27 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010445 (2001). 8 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K994068: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System, Cordis Corp. (1999) Summary page 1.
- K020682: Bard Luminexx 6 FR Biliary Stent and Delivery System, C.R. Bard, Inc. (2002)

## Most influential descendants
- K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System (2003), 9 descendants of its own
- 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

## Recalls of this device
- Apr 9, 2012 · Not classified · Z-1508-2012: Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a ster
- Apr 9, 2012 · Not classified · Z-1507-2012: Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a ster
- Jan 31, 2012 · Not classified · Z-1039-2012: Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.

## 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/K031777
Methodology: https://510kreport.com/methodology