510(k) K180530

Imager II Urology Torque Catheter by Boston Scientific Corporation — Product Code KOD

K180530 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Imager II Urology Torque Catheter". The FDA issued a decision of Substantially Equivalent on April 10, 2018. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.