510(k) Report

Devices descending from K022427

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052742Hepasphere MicrospheresBiosphere Medical, Inc.200611—
+1K034068Contour SE MicrospheresBoston Scientific Corp200410—
+2K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150—
+2K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128—
+2K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121—
+2K081768Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated20080—
+2K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+2K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.20061—
+3K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+3K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.20142—
+3K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+3K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+3K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+3K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+3K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+3K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080—
+4K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+4K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+4K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+4K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+4K171946Gel-BeadVascular Solutions, Inc.20171—
+4K162373LC Bead LUMIBiocompatibles UK Limited20160—
+5K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—