510(k) Report

Devices descending from K153141

7 later devices reach DyeVert Contrast Modulation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.20166—
+2K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc.20180—
+2K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.20171—
+2K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.20175—
+3K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc.20190—
+3K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.20182—
+3K171698Smart SyringeOsprey Medical, Inc.20171—