510(k) K191060

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit by Acist Medical Systems, Inc. — Product Code DXT

K191060 is an FDA 510(k) premarket notification submitted by Acist Medical Systems, Inc. for the device "ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit". The FDA issued a decision of Substantially Equivalent on July 18, 2019. 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.