510(k) Report

Devices descending from K071125

16 later devices reach Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+1K113658Amplatzer Vascular Plug 4Aga Medical Corp.201213—
+1K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.200715—
+2K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+2K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.20200—
+2K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+2K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+2K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+3K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+3K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+3K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+3K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+3K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+4K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+4K191680AZUR Vascular PlugMicroVention, Inc.20200—