510(k) K141209

EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES by Celonova Biosciences, Inc. — Product Code KRD

K141209 is an FDA 510(k) premarket notification submitted by Celonova Biosciences, Inc. for the device "EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES". The FDA issued a decision of Substantially Equivalent on August 7, 2014. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Celonova Biosciences, Inc. has at least 4 other 510(k) clearances on record.