DURACATH, GISH MODEL NO. DVAC-XXXX

DURACATH, GISH MODEL NO. DVAC-XXXX is an FDA 510(k)-cleared medical device (K863792) manufactured by Gish Biomedical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 1986. Regulation: 8.