# K060239: Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Mar 22, 2006 after 50 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- 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 K955347 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051621: Endoventions Alimaxx-E Esophageal Stent System, Alveolus, Inc. (2005) Summary page 1.
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System, Rusch Intl. (2003) Summary page 1.

## Indications for use
The Alveolus/Endoventions ALIMAXX-E DV™ Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

Source page: https://510kreport.com/device/K060239
Methodology: https://510kreport.com/methodology