510(k) K901562

CVIS INSIGHT IMAGING CATHETER by Cardiovascular Imaging Systems, Inc. — Product Code DXK

K901562 is an FDA 510(k) premarket notification submitted by Cardiovascular Imaging Systems, Inc. for the device "CVIS INSIGHT IMAGING CATHETER". The FDA issued a decision of Substantially Equivalent on July 9, 1990. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Cardiovascular Imaging Systems, Inc. has at least 10 other 510(k) clearances on record.