DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS

DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS is an FDA 510(k)-cleared medical device (K132947) manufactured by Boston Scientific Corp. 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 17, 2013. Regulation: 8.