LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 is an FDA 510(k)-cleared medical device (K090051) manufactured by Levitronix, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2009. Regulation: 8.