BLUE MAX II BALLOON DDILATATION CATHETER

BLUE MAX II BALLOON DDILATATION CATHETER is an FDA 510(k)-cleared medical device (K921254) 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 December 2, 1992. Regulation: 8.