510(k) Report

Devices descending from K071939

23 later devices reach Hydrocoil Embolic Systems (Hes) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+1K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+1K123384Azur CX Detachable 18MicroVention, Inc.20123—
+1K120630Azur Detachable 18MicroVention, Inc.201243
+1K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+1K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+2K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+2K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+2K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+2K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+2K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+2K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+2K122316Azur Detachable 35MicroVention, Inc.20120—
+3K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+3K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+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—
+4K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+4K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+5K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+5K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—