ENSITE VELOCITY SYSTEM, MODEL EE3000

ENSITE VELOCITY SYSTEM, MODEL EE3000 is an FDA 510(k)-cleared medical device (K101419) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2010. Regulation: 8.