# K010445: Precise Nitinol Stent Transhepatic Billary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Mar 16, 2001 after 30 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.
26 later devices descend from it; 4 cite it directly.
0 of 27 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
- K012993: Modification to Precise Nitinol Stent Transhepatic Biliary System (2001), 25 descendants of its own
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System (2002), 24 descendants of its own
- 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

Source page: https://510kreport.com/device/K010445
Methodology: https://510kreport.com/methodology