BLUE MAX - 20 BALLOON DILATATION CATHETER

BLUE MAX - 20 BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K972357) manufactured by 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 November 18, 1997. Regulation: 8.