MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221

MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221 is an FDA 510(k)-cleared medical device (K912084) 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 July 29, 1991. Regulation: 8.