510(k) Report

Devices descending from K030966

18 later devices reach Contour Emboli Pva and Fastracker-325 Infusion Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc.20142—
+1K100663Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321Boston Scientific Corporation20102—
+1K081768Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated20080—
+1K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.20061—
+1K034068Contour SE MicrospheresBoston Scientific Corp200410—
+1K033913ProgreatTerumo Medical Corp.20043—
+2K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.20181—
+2K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.20170—
+2K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc.20141—
+2K130259Bearing Nspva Embolization ParticlesMerit Medical Systems, Inc.20131—
+2K073417Embozene MicrospheresCelonova Biosciences, Inc.20086—
+2K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080—
+3K242794ONCOZENE MicrospheresVarian Medical Systems, Inc.20240—
+3K233813Bearing nsPVA Express™Merit Medical Systems, Inc.20230—
+3K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.20220—
+3K132675Embozene MicrospheresCelonova Biosciences, Inc.20134—
+3K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc.20132—
+4K162373LC Bead LUMIBiocompatibles UK Limited20160—