COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K984456) 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 January 10, 1999. Regulation: 8.