510(k) K210638

i-ED COIL System by Kaneka Medical America, LLC — Product Code HCG

K210638 is an FDA 510(k) premarket notification submitted by Kaneka Medical America, LLC for the device "i-ED COIL System". The FDA issued a decision of Substantially Equivalent on March 26, 2021. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Kaneka Medical America, LLC has at least 1 other 510(k) clearance on record.