THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM

THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM is an FDA 510(k)-cleared medical device (K052454) manufactured by Abbott Vascular Devices. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2005. Regulation: 8.