# K994068: S.M.a.R.T. Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Dec 23, 1999 after 21 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System: named in the summary without a submission number

## 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

## Indications for use
The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K994068
Methodology: https://510kreport.com/methodology