510(k) Report

Devices descending from K991549

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150870HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.201501
+1K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128—
+1K093813Occlusin 500 Artificial Embolization DeviceImbiotechnologies20100—
+1K052742Hepasphere MicrospheresBiosphere Medical, Inc.200611—
+1K050470Concentric Embolic PearlsConcentric Medical, Inc.20050—
+1K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp2003181
+1K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc.200241—
+2K220567Easi-Vue embolic microspheres SystemAbk Biomedical, Inc.20221—
+2K181300Embosphere MicrospheresBiosphere Medical, S.A.201891
+2K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+2K150876Bead BlockBiocompatibles UK, Ltd.20164—
+2K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150—
+2K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.20142—
+2K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+2K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+2K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121—
+2K100663Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321Boston Scientific Corporation20102—
+2K081768Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated20080—
+2K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.20061—
+2K034068Contour SE MicrospheresBoston Scientific Corp200410—
+2K033913ProgreatTerumo Medical Corp.20043—
+3K250971Embosphere MicrospheresBiosphere Medical, S.A.20250—
+3K234123Easi-Vue® embolic microspheres SystemAbk Biomedical, Inc.20240—
+3K183120EmboCube Embolization GelatinBiosphere Medical, S.A.20197—
+3K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+3K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+3K173871CalliSpheres Embolic Microspheres, 8Spheres Embolic MicrospheresSuzhou Hengrui Callisyn Biomedical Co., Ltd.20183—
+3K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+3K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.20181—
+3K171946Gel-BeadVascular Solutions, Inc.20171—
+3K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.20170—
+3K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+3K130259Bearing Nspva Embolization ParticlesMerit Medical Systems, Inc.20131—
+3K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+3K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080—
+4K250209Polyvinyl Alcohol Embolic MicrospheresCanyon Medical, Inc.20250—
+4K240873TEMBO Embolic SystemInstylla, Inc.20241—
+4K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+4K232934SunsphereHangzhou Yangshun Medical Technology Co.,Ltd20240—
+4K233813Bearing nsPVA Express™Merit Medical Systems, Inc.20230—
+4K213385GEMObsidio, Inc.20223Class I
+4K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.20220—
+4K210562HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd.20210—
+4K192480Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+4K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—
+4K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+4K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+5K253677Tembo Embolic SystemInstylla, Inc.20250—
+5K242507OBSIDIO™ Conformable EmbolicBoston Scientific20242—
+5K162373LC Bead LUMIBiocompatibles UK Limited20160—
+6K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation20260—
+6K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation20250—