ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET

ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET is an FDA 510(k)-cleared medical device (K970229) 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 February 12, 1998. Regulation: 8.