510(k) K172455

CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit by Volcano Corporation — Product Code IYO

K172455 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit". The FDA issued a decision of Substantially Equivalent on October 25, 2017. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Volcano Corporation has at least 10 other 510(k) clearances on record.