510(k) Report

Devices descending from K961794

39 later devices reach Fluid Administration Set - Contrast Manager through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083576Miser Contrast Management SystemMerit Medical Systems, Inc.20080—
+1K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc.20070—
+1K052252Contrast Media Transfer SetsB.Braun Medical, Inc.20050—
+1K040456Fleboset MultipleLaboratorios Grifols, S.A.200411—
+1K022431Medrad Transfer SetMedrad, Inc.200215—
+1K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec2000204
+2K243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals20250—
+2K171646ACISTCVi® Contrast Delivery SystemAcist Medical Systems, Inc.20184—
+2K102590Fleboset DoubleLaboratorios Grifols, S.A.20110—
+2K102073Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TSBenlan, Inc.20100—
+2K093182Set Gri-Fill 3.0Laboratorios Grifols, S.A.20101—
+2K082752QuickpinLaboratorios Grifols, S.A.20082—
+2K052744C2000 Automated Manifold KitAcist Medical Systems, Inc.2005141
+2K050339Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A.20056—
+2K031808Medrad Swabbable Valve Transfer SetMedrad, Inc.20032—
+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—
+3K170110Diana Medication Transfer SetIcu Medical, Inc.201811
+3K152441KIRO SetKiro Robotics S.L.20153—
+3K131478Contrast Conservation SystemOsprey Medical, Inc.201313—
+4K212530IVX Fluid Transfer SetOmnicell, Inc.202201
+4K203674B Dispensing LineAea Srl20210—
+4K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc.20201—
+4K190157Diana ChemoClave Transfer SetIcu Medical20190—
+4K162216Gri-Fill Peristaltic SetLaboratorios Grifols, S.A.20170—
+4K140425Contrast Modulation SystemOsprey Medical, Inc.201412—
+5K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…Acist Medical Systems, Inc.20260—
+5K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.20158—
+5K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc.20158—
+5K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…Osprey Medical20150—
+5K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.201510—
+6K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.20167—
+7K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.20166—
+8K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc.20180—
+8K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.20171—
+8K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.20175—
+9K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc.20190—
+9K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.20182—
+9K171698Smart SyringeOsprey Medical, Inc.20171—