
Terumo Cardiovascular Systems
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SARN CENTRIFUGAL PUMP is an FDA 510(k)-cleared medical device (K112229) manufactured by Terumo Cardiovascular Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2011. Regulation: 8.