SurfRider 13 Microcatheter

SurfRider 13 Microcatheter is an FDA 510(k)-cleared medical device (K251668) manufactured by Kaneka Americas Holding, 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 January 4, 2026. Regulation: 8.