510(k) Report

Devices descending from K052744

14 later devices reach C2000 Automated Manifold Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131478Contrast Conservation SystemOsprey Medical, Inc.201313—
+2K140425Contrast Modulation SystemOsprey Medical, Inc.201412—
+3K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.20158—
+3K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc.20158—
+3K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…Osprey Medical20150—
+3K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.201510—
+4K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.20167—
+5K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.20166—
+6K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc.20180—
+6K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.20171—
+6K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.20175—
+7K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc.20190—
+7K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.20182—
+7K171698Smart SyringeOsprey Medical, Inc.20171—