OLYMPUS VALVULOTOME W/DETACHABLE TIP

OLYMPUS VALVULOTOME W/DETACHABLE TIP is an FDA 510(k)-cleared medical device (K895878) manufactured by Olympus 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 January 1, 1990. Regulation: 8.