510(k) K160173

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) by Boston Scientific Corporation — Product Code DXK

K160173 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)". The FDA issued a decision of Substantially Equivalent on February 26, 2016. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.