510(k) K170385

CORE M2 Vascular System by Volcano Corporation — Product Code IYO

K170385 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "CORE M2 Vascular System". The FDA issued a decision of Substantially Equivalent on April 6, 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.