510(k) K200733

Opticross 35 15 MHz Peripheral Imaging Catheter by Boston Scientific Corporation — Product Code ITX

K200733 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Opticross 35 15 MHz Peripheral Imaging Catheter". The FDA issued a decision of Substantially Equivalent on Apr 17, 2020. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Boston Scientific Corporation has 238 other 510(k) clearances on record.