COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K002591) 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 September 12, 2000. Regulation: 8.