OLYMPUS ANGIOSCOPY IRRIGATION SHEATH

OLYMPUS ANGIOSCOPY IRRIGATION SHEATH is an FDA 510(k)-cleared medical device (K910933) 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 June 2, 1991. Regulation: 8.