ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER

ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER is an FDA 510(k)-cleared medical device (K900677) manufactured by Cook, 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 February 21, 1991. Regulation: 8.