510(k) K181042

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter by Boston Scientific Corporation — Product Code DXK

K181042 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter". The FDA issued a decision of Substantially Equivalent on May 17, 2018. 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.