510(k) K173891

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume by Vascular Solutions, Inc. — Product Code KRD

K173891 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume". The FDA issued a decision of Substantially Equivalent on January 19, 2018. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.