# K250209: Polyvinyl Alcohol Embolic Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Canyon Medical, Inc.
- Decided: Sep 23, 2025 after 242 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: 6 generations back to K961923 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173871: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres, Suzhou Hengrui Callisyn Biomedical Co., Ltd. (2018) Summary page 5.

## Indications for use
Polyvinyl Alcohol Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

Source page: https://510kreport.com/device/K250209
Methodology: https://510kreport.com/methodology