510(k) K192068

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

K192068 is an FDA 510(k) premarket notification submitted by Kaneka Pharma America, LLC for the device "i-ED COIL". The FDA issued a decision of Substantially Equivalent on April 25, 2020. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Kaneka Pharma America, LLC has at least 3 other 510(k) clearances on record.