510(k) Report

Devices descending from K052742

11 later devices reach Hepasphere Microspheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150—
+1K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128—
+1K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121—
+2K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+2K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.20142—
+2K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.20142—
+3K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+3K181021EmboCube Embolization GelatinBiosphere Medical, S.A.20181—
+3K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+3K171946Gel-BeadVascular Solutions, Inc.20171—
+4K183578Torpedo Gelatin FoamBiosphere Medical, S.A.20190—