GEL-BEAD EMBOLIZATION SPHERES

GEL-BEAD EMBOLIZATION SPHERES is an FDA 510(k)-cleared medical device (K133237) manufactured by Vascular Solutions, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2014. Regulation: 8.