510(k) Report

Devices descending from K963982

23 later devices reach Acist Angiographic Injector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991103Modification to Acist CL 100HAcist Medical Systems2000193
+1K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec2000204
+1K984058Acist Injector System, Model CL100 HAcist Medical Systems199920—
+2K171646ACISTCVi® Contrast Delivery SystemAcist Medical Systems, Inc.20184—
+2K131478Contrast Conservation SystemOsprey Medical, Inc.201313—
+2K052744C2000 Automated Manifold KitAcist Medical Systems, Inc.2005141
+3K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…Acist Medical Systems, Inc.20260—
+3K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…Acist Medical Systems, Inc.20192—
+3K140425Contrast Modulation SystemOsprey Medical, Inc.201412—
+4K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc.20201—
+4K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.20158—
+4K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc.20158—
+4K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…Osprey Medical20150—
+4K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.201510—
+5K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…Acist Medical Systems, Inc.20260—
+5K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.20167—
+6K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.20166—
+7K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc.20180—
+7K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.20171—
+7K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.20175—
+8K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc.20190—
+8K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.20182—
+8K171698Smart SyringeOsprey Medical, Inc.20171—