CAP-35 AND CAP35 F

CAP-35 AND CAP35 F is an FDA 510(k)-cleared medical device (K874924) 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 18, 1988. Regulation: 8.