510(k) K021015

ACIST PLUS 4 ANGIOGRAPHIC CATHETER by Acist Medical Systems — Product Code DQO

K021015 is an FDA 510(k) premarket notification submitted by Acist Medical Systems for the device "ACIST PLUS 4 ANGIOGRAPHIC CATHETER". The FDA issued a decision of Substantially Equivalent on April 26, 2002. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Acist Medical Systems has at least 10 other 510(k) clearances on record.