CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR is an FDA 510(k)-cleared medical device (K131179) manufactured by Thoratec Corp. 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 17, 2013. Regulation: 8.