510(k) Report

Devices descending from K171646

4 later devices reach ACISTCVi® Contrast Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…Acist Medical Systems, Inc.20260—
+1K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…Acist Medical Systems, Inc.20192—
+2K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc.20201—
+3K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…Acist Medical Systems, Inc.20260—