MS CLASSIQUE BALLOON CATHETER

MS CLASSIQUE BALLOON CATHETER is an FDA 510(k)-cleared medical device (K943298) manufactured by Meadox Medicals, Div. Boston Scientific Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 1994. Regulation: 8.