# K003336: Modification to S.M.a.R.T Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Nov 22, 2000 after 28 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
No predicates in its family tree.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (2008), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K003336
Methodology: https://510kreport.com/methodology