ROTAFLOW CENTRIFUGAL PUMP SYSTEM

ROTAFLOW CENTRIFUGAL PUMP SYSTEM is an FDA 510(k)-cleared medical device (K991864) manufactured by Jostra Medizintechnik AG. 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 30, 2000. Regulation: 8.