SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF

SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF is an FDA 510(k)-cleared medical device (K912604) manufactured by Aries Medical, 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 October 27, 1991. Regulation: 8.