# K993091: Palmaz XL Tanshepatic Biliary Stents

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Oct 29, 1999 after 43 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.
No later device cites it as a predicate yet.
0 of 1 device 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 PALMAZ® Balloon Expandable Transhepatic Biliary Stents: named in the summary without a submission number

## Indications for use
The Cordis PALMAZ® XL Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K993091
Methodology: https://510kreport.com/methodology