Terumo Advanced Perfusion System 1

Terumo Advanced Perfusion System 1 is an FDA 510(k)-cleared medical device (K221895) 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 April 17, 2023. Regulation: 8.