510(k) K893042

CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM by Endosonics Corp. — Product Code IYN

K893042 is an FDA 510(k) premarket notification submitted by Endosonics Corp. for the device "CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 19, 1989. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Endosonics Corp. has at least 10 other 510(k) clearances on record.