510(k) Report

Devices descending from K193462

21 later devices reach ClotTriever Thrombectomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210190ClotTriever Thrombectomy SystemIrani Medical, Inc.202120—
+2K210689ClotTriever Thrombectomy SystemInari Medical, Inc.202119—
+3K220887Mini-ClotTriever Thrombectomy SystemInari Medical20222—
+3K212632ClotTriever Thrombectomy SystemInari Medical, Inc.202115—
+4K223210ClotTriever XL CatheterInari Medical, Inc.20231Class I
+4K230494ClotTriever BOLD CatheterInari Medical, Inc.20230—
+4K223613InThrill Thrombectomy SystemInari Medical, Inc.20231—
+4K223609RevCore™ Thrombectomy Catheter.Inari Medical, Inc.20232—
+4K223891Cobra Catheter SystemEndovascular Engineering20232—
+4K221531ClotTriever Thrombectomy SystemInari Medical, Inc.20230—
+4K223000Artix BGInari Medical20233—
+4K220415Protrieve SheathInari Medical, Inc.20220—
+5K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+5K251185Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)Intervene20250—
+5K250421InThrill™ Thrombectomy SystemInari Medical, Inc.20250—
+5K242557ClotTriever XL Catheter (41-102)Inari Medical, Inc.20240—
+5K234034VenaCore Thrombectomy Catheter (46-101)Inari Medical, Inc.20240—
+5K230912Artix BGInari Medical20232—
+6K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+6K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc.202411
+7K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.20260—