510(k) K162999

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System by MicroVention, Inc. — Product Code HCG

K162999 is an FDA 510(k) premarket notification submitted by MicroVention, Inc. for the device "V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System". The FDA issued a decision of Substantially Equivalent on March 29, 2017. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. MicroVention, Inc. has at least 10 other 510(k) clearances on record.