FLEXIBLE INTRACARDIAC SUCTION DEVICE

FLEXIBLE INTRACARDIAC SUCTION DEVICE is an FDA 510(k)-cleared medical device (K905008) 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 January 22, 1991. Regulation: 8.