# K991028: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Aug 4, 1999 after 128 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
Longest line of descent: 2 generations back to K905720 (1991). 6 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905720: Palmaz Biliary Stent, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K911581: Palmaz (TM) Balloon-Expandable Stent, Modification, Johnson & Johnson Interventional Systems (1991) Summary page 1.
- K964688: Long Medium Palmaz-Schatz Balloon Expandable Stent, Cordis Corp. (1997) Summary page 1.
- K990631: Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC, Cordis Corp. (1999). Cleared while this submission was under review Summary page 2.
- K971448: Cordis Opta LP Pta Balloon Catheter, Cordis Corp. (1997) Summary page 2.
- K981407: Opta LP Pta Balloon Catheter/Powerflex Plus Pta Balloon Catheter, Cordis Corp. (1998) Summary page 2.

## Most influential descendants
- K992755: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube (1999), 17 descendants of its own
- K994156: Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B (2000), 11 descendants of its own
- K012056: Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System (2001), 9 descendants of its own
- K012090: Cordis Palmaz Genesis Transhepatic Biliary Stent (2001), 6 descendants of its own
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System (2001), 5 descendants of its own

## Indications for use
The PALMAZ CORINTHIAN Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree. Certain sizes of the OPTA LP catheters are indicated for deployment of 6-10 mm diameter X 4-10 cm length PALMAZ CORINTHIAN Transhepatic Riliary Stents. The clinical indications for these stents are described in their Instructions for Use. Additionally, the OPTA LP catheter is intended to dilatc stenoses i iliae, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K991028
Methodology: https://510kreport.com/methodology