# K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Mar 18, 2008 after 214 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 K964688 (1997). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060057: Protege Everflex Self-Expanding Biliary Stent System, Ev3, Inc. (2006) Summary page 1.
- K033537: Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005, Abbott Laboratories (2003) Summary page 1.
- K003793: Bard Luminexx Biliary Stent, C.R. Bard, Inc. (2001) Summary page 2.
- K032025: Sentinol Nitinol Billary Stent System, Boston Scientific Corp (2003) Summary page 2.
- K002143: Dynalink Biliary Self-Expanding Stent System, Guidant Corp. (2000) Summary page 2.

## Most influential descendants
- K262913: Protégé™ EverFlex™ Self-expanding Peripheral Stent System (2026), 0 descendants of its own
- K111627: Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 0 descendants of its own

## Indications for use
The Prot6gb® EverFlex' Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K072301
Methodology: https://510kreport.com/methodology