HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH

HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH is an FDA 510(k)-cleared medical device (K132720) manufactured by Merit Medical Systems, 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 11, 2014. Regulation: 8.