510(k) K254221

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

K254221 is an FDA 510(k) premarket notification submitted by Balt USA, LLC for the device "Optima Coil System (OptiOne Coil System)". The FDA issued a decision of Substantially Equivalent on January 27, 2026. 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.