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Terumo Cardiovascular Systems Corporation
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ADAPTERS WITH X-COATING is an FDA 510(k)-cleared medical device (K022918) manufactured by Terumo Cardiovascular Systems Corporation. 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 26, 2002. Regulation: 8.