COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR

COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR is an FDA 510(k)-cleared medical device (K971669) 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 July 22, 1997. Regulation: 8.