510(k) K052744

C2000 AUTOMATED MANIFOLD KIT by Acist Medical Systems, Inc. — Product Code DXT

K052744 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "C2000 AUTOMATED MANIFOLD KIT". The FDA issued a decision of Substantially Equivalent on December 16, 2005. 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.