510(k) Report

Devices descending from K101406

30 later devices reach Angiojet Solent Proxi Thrombectomy Set Model 109676-001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113428Angiojet Ultra DVX Thrombectomy SetMedrad, Inc.20110—
+1K111182Angiojet Solent Omni Thrombectomy SetMedrad, Inc.2011281
+2K151313ZelanteDVT Thrombectomy SetBoston Scientific Corporation201526—
+2K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc.201201
+3K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceBoston Scientific Corporation20203—
+3K193462ClotTriever Thrombectomy SystemInari Medical202021—
+4K243549JETi Hydrodynamic Thrombectomy SystemAbbott Medical20250—
+4K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+4K210190ClotTriever Thrombectomy SystemIrani Medical, Inc.202120—
+5K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+5K210689ClotTriever Thrombectomy SystemInari Medical, Inc.202119—
+6K220887Mini-ClotTriever Thrombectomy SystemInari Medical20222—
+6K212632ClotTriever Thrombectomy SystemInari Medical, Inc.202115—
+7K223210ClotTriever XL CatheterInari Medical, Inc.20231Class I
+7K230494ClotTriever BOLD CatheterInari Medical, Inc.20230—
+7K223613InThrill Thrombectomy SystemInari Medical, Inc.20231—
+7K223609RevCore™ Thrombectomy Catheter.Inari Medical, Inc.20232—
+7K223891Cobra Catheter SystemEndovascular Engineering20232—
+7K221531ClotTriever Thrombectomy SystemInari Medical, Inc.20230—
+7K223000Artix BGInari Medical20233—
+7K220415Protrieve SheathInari Medical, Inc.20220—
+8K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+8K251185Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)Intervene20250—
+8K250421InThrill™ Thrombectomy SystemInari Medical, Inc.20250—
+8K242557ClotTriever XL Catheter (41-102)Inari Medical, Inc.20240—
+8K234034VenaCore Thrombectomy Catheter (46-101)Inari Medical, Inc.20240—
+8K230912Artix BGInari Medical20232—
+9K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+9K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc.202411
+10K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.20260—