510(k) K242794

ONCOZENE Microspheres by Varian Medical Systems, Inc. — Product Code KRD

K242794 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "ONCOZENE Microspheres". The FDA issued a decision of Substantially Equivalent on October 16, 2024. 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.