# K021898: Smart Control Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Aug 14, 2002 after 65 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: 2 generations back to K010445 (2001). 5 ancestors in all.
24 later devices descend from it; 8 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012993: Modification to Precise Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2001)
- K001843: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2000)
- K971010: Peripheral Transluminal Angioplasty Catheters, Cordis Corp. (1997) Summary page 1.
- K011080: Bridge SE Self-Expanding Stent Delivery System, Medtronic Ave, Inc. (2001)

## Most influential descendants
- K031777: Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System (2003), 10 descendants of its own
- 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

## 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 SMART Control Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K021898
Methodology: https://510kreport.com/methodology