ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS

ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS is an FDA 510(k)-cleared medical device (K032622) manufactured by Medtronic Vascular. 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 2, 2003. Regulation: 8.