# K012993: Modification to Precise Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Oct 5, 2001 after 29 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010445 (2001). 1 ancestor in all.
25 later devices descend from it; 3 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)
- K010445: Precise Nitinol Stent Transhepatic Billary System, Cordis Corp. (2001) Summary page 1.

## Most influential descendants
- 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
- K071646: Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120 (2008), 5 descendants of its own

## Recalls of this device
- Nov 7, 2002 · Not classified · Z-0323-03: Field complaints of marker band spacing being out of spec.

## Indications for use
The Precise™ Nitinol Stent Transhepatic Biliary System (6F) is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K012993
Methodology: https://510kreport.com/methodology