# K020052: Smart Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Feb 11, 2002 after 34 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: 1 generation back to K001843 (2000). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001843: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2000) Summary page 1.

## Most influential descendants
- K033393: Absolute .035 Self-Expanding Biliary Stent System (2003), 3 descendants of its own
- K072720: Alimaxx-B Uncovered Biliary Stent System (2008), 1 descendant of its own
- K093947: Alimaxx-B Uncovered Biliary Stent System Endoscopic (2010), 0 descendants of its own
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The Cordis SM.A.R.T.™ Ni_tinol Stent Transhepatic Biliary System — 40 c¢m is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K020052
Methodology: https://510kreport.com/methodology