510(k) K233420

Axium Detachable Coil; Axium Prime Detachable Coil by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular — Product Code HCG

K233420 is an FDA 510(k) premarket notification submitted by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular for the device "Axium Detachable Coil; Axium Prime Detachable Coil". The FDA issued a decision of Substantially Equivalent on November 7, 2023. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular has at least 2 other 510(k) clearances on record.