CATHCAP, CAT. NO. CC100 SERIES

CATHCAP, CAT. NO. CC100 SERIES is an FDA 510(k)-cleared medical device (K911519) 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 21, 1991. Regulation: 8.