coraForce and coraFlex Support Catheters

coraForce and coraFlex Support Catheters is an FDA 510(k)-cleared medical device (K201811) manufactured by Reflow Medical, 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 October 25, 2020. Regulation: 8.