AB-180 XC SYSTEM, MODEL AB-180XC

AB-180 XC SYSTEM, MODEL AB-180XC is an FDA 510(k)-cleared medical device (K991783) manufactured by Cardiacassist, 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 October 31, 2000. Regulation: 8.