510(k) Report

Devices descending from K031852

30 later devices reach Sapphire Detachable Fiber Coils through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033372Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple ModelsMicro Therapeutics, Inc.200429—
+2K041649Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc.200428—
+3K060747FX Detachable Coil SystemMicro Therapeutics, Inc.2007232
+3K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc.200527—
+4K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+4K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+4K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+4K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+4K060625Nexus Detachable Coil System, Morpheus 3D CSRMicro Therapeutics, Inc.20060—
+4K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc.200524—
+4K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc.200524—
+5K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+5K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+5K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+5K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+5K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+5K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+6K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+6K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+6K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+6K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+6K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+6K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+7K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+7K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+7K191680AZUR Vascular PlugMicroVention, Inc.20200—
+7K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+7K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+8K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+8K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—