510(k) K202850

Concerto Versa, Detachable Coil by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code KRD

K202850 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Concerto Versa, Detachable Coil". The FDA issued a decision of Substantially Equivalent on February 9, 2021. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.