ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit is an FDA 510(k)-cleared medical device (K191060) manufactured by Acist Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2019. Regulation: 8.