SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX

SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX is an FDA 510(k)-cleared medical device (K863791) 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 24, 1987. Regulation: 8.