510(k) K901691

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE by Cardiovascular Imaging Systems, Inc. — Product Code DQO

K901691 is an FDA 510(k) premarket notification submitted by Cardiovascular Imaging Systems, Inc. for the device "CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE". The FDA issued a decision of Substantially Equivalent on Jul 6, 1990. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Cardiovascular Imaging Systems, Inc. has at least 10 other 510(k) clearances on record.