CORDIS PEEL-AWAY INSERTION TOOL

CORDIS PEEL-AWAY INSERTION TOOL is an FDA 510(k)-cleared medical device (K910688) manufactured by Cordis 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 May 15, 1991. Regulation: 8.