510(k) K040298

ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS by Acist Medical Systems, Inc. — Product Code DXT

K040298 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS". The FDA issued a decision of Substantially Equivalent on March 15, 2004. 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.