COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 is an FDA 510(k)-cleared medical device (K030462) manufactured by Cobe Cardiovascular, 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 March 5, 2003. Regulation: 8.