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Cardiomedics, Inc.
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CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 is an FDA 510(k)-cleared medical device (K050172) manufactured by Cardiomedics, 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 30, 2005. Regulation: 8.