# K033909: Wavemax Balloon-Expandable Transhepatic Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 17, 2004 after 62 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: 7 generations back to K905720 (1991). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012590: Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System, Cordis Corp. (2001)
- K033537: Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005, Abbott Laboratories (2003) Summary page 1.

## Most influential descendants
- K041962: Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605 (2004), 0 descendants of its own

## Indications for use
The Abbott Vascular Devices wavemaXTM Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K033909
Methodology: https://510kreport.com/methodology