510(k) K162524

AZUR CX Detachable 18 Peripheral Coil System by MicroVention, Inc. — Product Code KRD

K162524 is an FDA 510(k) premarket notification submitted by MicroVention, Inc. for the device "AZUR CX Detachable 18 Peripheral Coil System". The FDA issued a decision of Substantially Equivalent on March 3, 2017. 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.