510(k) K130259

BEARING NSPVA EMBOLIZATION PARTICLES by Merit Medical Systems, Inc. — Product Code NAJ

K130259 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "BEARING NSPVA EMBOLIZATION PARTICLES". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids), a Class II device regulated under 21 CFR 870.3300. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.