510(k) K223386

Optima Coil System by Balt USA, LLC — Product Code HCG

K223386 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "Optima Coil System". The FDA issued a decision of Substantially Equivalent on December 6, 2022. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Balt USA, LLC has at least 10 other 510(k) clearances on record.