# K030409: Smart Nitinol Stent Endoscopic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Mar 10, 2003 after 31 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: 3 generations back to K010445 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003365: S.M.a.R.T Nitinol Stent Endosopic Billary System (Various), Cordis Corp. (2000)
- 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)

## Indications for use
The Cordis S.M.A.R.T.TMNitinol Stent Endoscopic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K030409
Methodology: https://510kreport.com/methodology