510(k) K944004

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) by Endosonics Corp. — Product Code IYO

K944004 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)". The FDA issued a decision of Substantially Equivalent on May 4, 1995. 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.