510(k) K984627

AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER by Arterial Vascular Engineering, Inc. — Product Code DQO

K984627 is an FDA 510(k) premarket notification submitted by Arterial Vascular Engineering, Inc. for the device "AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER". The FDA issued a decision of Substantially Equivalent on July 27, 1999. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Arterial Vascular Engineering, Inc. has at least 2 other 510(k) clearances on record.