NEW BLUE MAX BALLOON DILATATION CATHETER

NEW BLUE MAX BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K934191) 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 8, 1993. Regulation: 8.