Direxion and Direxion HI-FLO Torqueable Microcatheters

Direxion and Direxion HI-FLO Torqueable Microcatheters is an FDA 510(k)-cleared medical device (K163701) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2017. Regulation: 8.