510(k) K250209

Polyvinyl Alcohol Embolic Microspheres by Canyon Medical, Inc. — Product Code KRD

K250209 is an FDA 510(k) premarket notification submitted by Canyon Medical, Inc. for the device "Polyvinyl Alcohol Embolic Microspheres". The FDA issued a decision of Substantially Equivalent on September 23, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Canyon Medical, Inc. has at least 4 other 510(k) clearances on record.