# K980823: Cordis Nitinol Stent and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Dec 18, 1998 after 290 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. The FDA summary names its predicate without a number.
- (no number) Wallstent® Biliary Endoprosthesis with Unistep™ Delivery System: named in the summary without a submission number
- (no number) Symphony™ Nitinol Stent Transhepatic Biliary System: named in the summary without a submission number
- (no number) Bard® Memotherm® Nitinol Stent Transhepatic Biliary Endoprosthesis: named in the summary without a submission number
- (no number) PALMAZ™ Balloon-Expandable Stent: named in the summary without a submission number
- (no number) PALMAZ™ & PALMAZ-SCHATZ™ Balloon-Expandable Stent and Stent Delivery Systems: named in the summary without a submission number
- (no number) Long Medium PALMAZ-SCHATZ™ Balloon-Expandable Stent: named in the summary without a submission number

## Most influential descendants
- K031331: WZ Self-Expanding Stent Transhepatic Biliary System (2003), 4 descendants of its own
- K032929: Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models 14819, 14820, 14821, 14822, 14822 (2003), 3 descendants of its own
- K050103: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (2005), 2 descendants of its own
- K050501: Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (2005), 1 descendant of its own
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The Cordis Nitinol Stent and Delivery System is intended for palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K980823
Methodology: https://510kreport.com/methodology