# K980653: Perflex Stainless Steel Stent and Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jun 9, 1998 after 118 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: 3 generations back to K911292 (1991). 15 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 23 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.
- K955728: Cordis Biliary Stent, Cordis Corp. (1996) Summary page 1.
- K964688: Long Medium Palmaz-Schatz Balloon Expandable Stent, Cordis Corp. (1997) Summary page 1.
- K972825: OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon Catheter, Palmaz Balloon Expandab, Cordis Corp. (1997) Summary page 1.
- K885180: Expandable Biliary Stent Endoprosthesis, Schneider Intl., Ltd. (1989) Summary page 2.
- K896163: Schneider Stent Wallstent Endoscopic Biliary Endo., Schneider Stent (1989) Summary page 2.
- K911292: Schneider Wallstent (R), Pfizer Hospital Products Group, Inc. (1991) Summary page 2.
- K914277: Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY, Schneider U.S. Stent Div. (1991) Summary page 2.
- K923993: Wallstent Biliary Endoprotheses, Schneider U.S. Stent Div. (1994) Summary page 2.
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 2.
- K964119: Wallstent Transhepatic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1997) Summary page 2.

## Most influential descendants
- K991929: Intrastent (1999), 3 descendants of its own
- K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System (1999), 2 descendants of its own
- K993904: Intrastent Doublestrut LD (2000), 1 descendant of its own
- K060817: Omnilink. 018 Biliary Stent System (2006), 0 descendants of its own
- K053459: Omnilink .035 Biliary Stent System (2006), 0 descendants of its own

## Indications for use
The Cordis PERFLEX Stainless Steel Stent and Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K980653
Methodology: https://510kreport.com/methodology