ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET

ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET is an FDA 510(k)-cleared medical device (K924607) manufactured by Arrow Intl., Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 1993. Regulation: 8.