# K212057: Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

- Pathway: 510(k) (Traditional)
- Applicant: Artventive Medical Group, Inc.
- Decided: Mar 1, 2022 after 243 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K951256 (1995). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150402: Endoluminal Occlusion System-EOS, Artventive Medical Group, Inc. (2015) Summary page 4.

## Indications for use
The ArtVentive Endoluminal Occlusion System - EOS-X is indicated for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K212057
Methodology: https://510kreport.com/methodology