510(k) K213398

EMBOLD Fibered Detachable Coil System by Boston Scientific Corporation — Product Code KRD

K213398 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "EMBOLD Fibered Detachable Coil System". The FDA issued a decision of Substantially Equivalent on Apr 12, 2022. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Boston Scientific Corporation has 238 other 510(k) clearances on record.