# K234123: Easi-Vue® embolic microspheres System

- Pathway: 510(k) (Traditional)
- Applicant: Abk Biomedical, Inc.
- Decided: Feb 13, 2024 after 47 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: 5 generations back to K961923 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220567: Easi-Vue embolic microspheres System, Abk Biomedical, Inc. (2022) Summary page 5.

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

Source page: https://510kreport.com/device/K234123
Methodology: https://510kreport.com/methodology