510(k) K102527

IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER by Boston Scientific Corporation — Product Code KOD

K102527 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER". The FDA issued a decision of Substantially Equivalent on November 5, 2010. 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.