# K042969: Modification to Smart Control Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Nov 8, 2004 after 11 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010445 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023217: Modification to Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2002) Summary page 1.
- K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2003) Summary page 1.

## 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

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

Source page: https://510kreport.com/device/K042969
Methodology: https://510kreport.com/methodology