510(k) Report

Devices descending from K913312

80 later devices reach Helix Shaped Coils with Dacron Fibers, Modified through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc.199879—
+2K123560Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…Codman & Shurtleff, Inc.20130—
+2K983483Vascular Occlusion SystemCordis Neurovascular, Inc.199978—
+3K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+3K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc.200732—
+3K993455Flipper Detachable Embolization CoilCook, Inc.200041—
+4K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+4K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+4K123384Azur CX Detachable 18MicroVention, Inc.20123—
+4K120630Azur Detachable 18MicroVention, Inc.201243
+4K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+4K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+4K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+4K063619Flipper Detachable Embolization CoilsCook, Inc.20061—
+4K031810Amplatzer Vascular PlugAga Medical Corp.2003381
+5K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+5K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+5K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+5K150964MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated20150—
+5K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+5K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+5K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+5K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+5K123696Medusa Vascular PlugEndoshape, Inc.20131—
+5K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+5K122316Azur Detachable 35MicroVention, Inc.20120—
+5K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+5K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+5K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp.200716—
+5K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation200520—
+6K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+6K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+6K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+6K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+6K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+6K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+6K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+6K140796Medusa Vascular Plug,Endoshape, Inc.20140—
+6K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+6K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+6K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+6K113658Amplatzer Vascular Plug 4Aga Medical Corp.201213—
+6K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+6K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+6K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.200715—
+7K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+7K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+7K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+7K211563Pitch-PatchsXiros, Ltd.20212—
+7K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+7K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+7K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+7K191680AZUR Vascular PlugMicroVention, Inc.20200—
+7K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.20200—
+7K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+7K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+7K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+7K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+7K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+7K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+7K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+7K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+8K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+8K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+8K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+8K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+8K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+8K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+8K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+8K090288Orthadapt PRPegasus Biologics, Inc.20097—
+9K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+9K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+9K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+9K112567Biomerix AssureBiomerix Corporation20110—
+9K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+10K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+11K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+11K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+11K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+12K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—