MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH

MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH is an FDA 510(k)-cleared medical device (K062446) manufactured by Terumo Medical 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 October 22, 2006. Regulation: 8.