SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS

SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS is an FDA 510(k)-cleared medical device (K944219) 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 June 29, 1995. Regulation: 8.