FlexCath Select Steerable Shealth and Dilator

FlexCath Select Steerable Shealth and Dilator is an FDA 510(k)-cleared medical device (K163268) 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 February 1, 2017. Regulation: 8.