# K023217: Modification to Smart Control Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Oct 25, 2002 after 29 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: 3 generations back to K010445 (2001). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 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)
- K001843: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2000)

## Most influential descendants
- K042969: Modification to Smart Control Nitinol Stent Transhepatic Biliary System (2004), 0 descendants of its own
- K031197: Modification to Smart Control Nitinol Stent Transhepatic Biliary System (2003), 0 descendants of its own

## Recalls of this device
- Feb 3, 2003 · Not classified · Z-0707-03: The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.

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

Source page: https://510kreport.com/device/K023217
Methodology: https://510kreport.com/methodology