510(k) K223050

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) by MicroVention, Inc. — Product Code KRD

K223050 is an FDA 510(k) premarket notification submitted by MicroVention, Inc. for the device "AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)". The FDA issued a decision of Substantially Equivalent on December 21, 2022. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. MicroVention, Inc. has at least 10 other 510(k) clearances on record.