Wingman 18 Crossing Catheter

Wingman 18 Crossing Catheter is an FDA 510(k)-cleared medical device (K160848) 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 July 13, 2016. Regulation: 8.