510(k) K010390

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS by Acist Medical Systems, Inc. — Product Code DXT

K010390 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS". The FDA issued a decision of Substantially Equivalent on March 9, 2001. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Acist Medical Systems, Inc. has at least 10 other 510(k) clearances on record.