510(k) Report

Devices descending from K113658

13 later devices reach Amplatzer Vascular Plug 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+1K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+1K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+1K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+2K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+2K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+2K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+2K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+2K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+2K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+3K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+3K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+3K191680AZUR Vascular PlugMicroVention, Inc.20200—