510(k) K893837

CVIS ULTRA-SCAN ONE IMAGING CATHETER by Cardiovascular Imaging Systems, Inc. — Product Code IYO

K893837 is an FDA 510(k) premarket notification submitted by Cardiovascular Imaging Systems, Inc. for the device "CVIS ULTRA-SCAN ONE IMAGING CATHETER". The FDA issued a decision of Substantially Equivalent on Aug 22, 1989. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Cardiovascular Imaging Systems, Inc. has at least 10 other 510(k) clearances on record.