510(k) K242608

Embozene Color-Advanced Microspheres by Varian Medical Systems, Inc. — Product Code KRD

K242608 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Embozene Color-Advanced Microspheres". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.