# K032137: Precise RX Nitinol Stent Transhepatic Biliary System

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Sep 17, 2003 after 68 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: 5 generations back to K911292 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012993: Modification to Precise Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2001)
- K010445: Precise Nitinol Stent Transhepatic Billary System, Cordis Corp. (2001)
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2002)
- K012822: Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-XXX, Boston Scientific Scimed, Inc. (2001)
- K020682: Bard Luminexx 6 FR Biliary Stent and Delivery System, C.R. Bard, Inc. (2002)

## Recalls of this device
- Jan 13, 2004 · Not classified · Z-0909-04: Air may be introduced into this Stent system when used with certain size acessory devices.

## Indications for use
The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K032137
Methodology: https://510kreport.com/methodology