FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) is an FDA 510(k)-cleared medical device (K123591) manufactured by Medtronic Cryocath, LP. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2012. Regulation: 8.