SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG is an FDA 510(k)-cleared medical device (K050111) manufactured by Cobe Cardiovascular, 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 March 7, 2005. Regulation: 8.