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Terumo Cardiovascular Systems Corp.
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CAPIOX RX HARDSHELL RESERVOIR is an FDA 510(k)-cleared medical device (K013526) manufactured by Terumo Cardiovascular Systems 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 November 14, 2001. Regulation: 8.