PRUITT ARTERIAL OCCLUSION CHOLANG. CATH

PRUITT ARTERIAL OCCLUSION CHOLANG. CATH is an FDA 510(k)-cleared medical device (K812111) manufactured by Bionomy, 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 November 15, 1981. Regulation: 8.