# K220567: Easi-Vue embolic microspheres System

- Pathway: 510(k) (Traditional)
- Applicant: Abk Biomedical, Inc.
- Decided: Sep 7, 2022 after 191 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: 4 generations back to K961923 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K234123: Easi-Vue® embolic microspheres System (2024), 0 descendants of its own

## Indications for use
Easi-VueIm embolic microspheres System is intended for embolization of arteriovenous malformations and hypervascular tumors.

Source page: https://510kreport.com/device/K220567
Methodology: https://510kreport.com/methodology