OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE

OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE is an FDA 510(k)-cleared medical device (K982733) manufactured by The Olympus Optical Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 1998. Regulation: 8.