510(k) K203432

Axium Detachable Coil; Axium Prime Detachable Coil by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code HCG

K203432 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Axium Detachable Coil; Axium Prime Detachable Coil". The FDA issued a decision of Substantially Equivalent on July 7, 2021. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.