INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH

INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH is an FDA 510(k)-cleared medical device (K842798) manufactured by American Edwards Laboratories. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 1984. Regulation: 8.