510(k) Report

Devices descending from DEN160040

4 later devices reach Embosphere Microspheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203276Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm…Biocompatibles UK Ltd (Part of Boston Scientific Corporation20210—
+1K192684HydroPearl MicrospheresMicroVention, Inc.202001
+1K180102Embozene Color-Advanced MicrospheresBoston Scientific20181—
+2K242608Embozene Color-Advanced MicrospheresVarian Medical Systems, Inc.20250—