510(k) Report

Devices descending from K034068

10 later devices reach Contour SE Microspheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081768Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated20080—
+1K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+1K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.20061—
+2K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+2K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+2K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+2K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+2K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080—
+3K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+3K162373LC Bead LUMIBiocompatibles UK Limited20160—