SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM

SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K062387) manufactured by Boston Scientific. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2006. Regulation: 8.