FlexCath Advance Steerable Sheath and Dilator

FlexCath Advance Steerable Sheath and Dilator is an FDA 510(k)-cleared medical device (K183174) 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 November 25, 2018. Regulation: 8.