510(k) Report

Devices descending from K031810

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+1K123696Medusa Vascular PlugEndoshape, Inc.20131—
+1K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp.200716—
+1K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation200520—
+2K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+2K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+2K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+2K140796Medusa Vascular Plug,Endoshape, Inc.20140—
+2K113658Amplatzer Vascular Plug 4Aga Medical Corp.201213—
+2K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+2K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.200715—
+3K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+3K211563Pitch-PatchsXiros, Ltd.20212—
+3K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.20200—
+3K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+3K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+3K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+3K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+4K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+4K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+4K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+4K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+4K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+4K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+5K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+5K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+5K191680AZUR Vascular PlugMicroVention, Inc.20200—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K112567Biomerix AssureBiomerix Corporation20110—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—