FloPump 57mL Centrifugal Pump

FloPump 57mL Centrifugal Pump is an FDA 510(k)-cleared medical device (K193663) manufactured by International Biophysics 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 March 9, 2021. Regulation: 8.