510(k) K163701

Direxion and Direxion HI-FLO Torqueable Microcatheters by Boston Scientific Corporation — Product Code KRA

K163701 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Direxion and Direxion HI-FLO Torqueable Microcatheters". The FDA issued a decision of Substantially Equivalent on May 16, 2017. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Boston Scientific Corporation has 238 other 510(k) clearances on record.