CPS-3000 CARDIOPLEGIA RESERVOIR

CPS-3000 CARDIOPLEGIA RESERVOIR is an FDA 510(k)-cleared medical device (K861102) manufactured by Gish Biomedical, 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 May 27, 1986. Regulation: 8.