MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET

MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET is an FDA 510(k)-cleared medical device (K082670) manufactured by Medtronic, 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 December 3, 2008. Regulation: 8.