
Cardiacassist, Inc.
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TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 is an FDA 510(k)-cleared medical device (K061369) 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 August 21, 2006. Regulation: 8.