510(k) Report

Devices descending from K191060

2 later devices reach ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc.20201—
+2K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…Acist Medical Systems, Inc.20260—