# K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Feb 6, 2008 after 505 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). 12 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2003) Summary page 1.
- K003336: Modification to S.M.a.R.T Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2000) Summary page 1.
- K010445: Precise Nitinol Stent Transhepatic Billary System, Cordis Corp. (2001) Summary page 1.
- K060057: Protege Everflex Self-Expanding Biliary Stent System, Ev3, Inc. (2006) Summary page 1.

## Most influential descendants
- K111766: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems (2011), 2 descendants of its own
- K122546: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 1 descendant of its own
- K130591: Supera Veritas (2013), 0 descendants of its own
- K111627: Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 0 descendants of its own

## 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 S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K062798
Methodology: https://510kreport.com/methodology