510(k) K963290

COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM by Endosonics Corp. — Product Code IYO

K963290 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 6, 1997. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Endosonics Corp. has at least 10 other 510(k) clearances on record.