EXACTA PERCUTANEOUS INTRODUCER SHEATH

EXACTA PERCUTANEOUS INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K941428) manufactured by Ohmeda Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 5, 1994. Regulation: 8.