VitalFlowTM Centrifugal Pump

VitalFlowTM Centrifugal Pump is an FDA 510(k)-cleared medical device (K223898) manufactured by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 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 24, 2023. Regulation: 8.