M-BOLUS EMBOLIC MICROSPHERES

M-BOLUS EMBOLIC MICROSPHERES is an FDA 510(k)-cleared medical device (K052509) manufactured by Scion Cardio-Vascular, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 2006. Regulation: 8.