510(k) Report

Devices descending from K942010

54 later devices reach Vascu-Guard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC20085—
+1K041736Pfa PatchPeritec Biosciences, LLC200512—
+1K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc.200417—
+1K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc.20041—
+1K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc.1998313
+1K963368Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative…Glycar, Inc.19970—
+2K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.202201
+2K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.202201
+2K190882XenoSure Biologic PatchLemaitre Vascular20200—
+2K182493Bovine Pericardial Tissue PatchTisgenx20190—
+2K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC20170—
+2K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.20151—
+2K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc.20141Class I
+2K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+2K130872CardiocelCelxcel Pty, Ltd.20143—
+2K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+2K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K090288Orthadapt PRPegasus Biologics, Inc.20097—
+2K063556Peripatch Endo-SleevePm Devices, Inc.20070—
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+2K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Synovis Surgical Innovations2004241
+2K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc.20031—
+3K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+3K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+3K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+3K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K130997NeoveilGunze Limited20133—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K101961Tigerpaw SystemLaax, Inc.20102—
+3K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+3K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations200448
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K111064Tigerpaw System IILaax, Inc.20111Class I
+4K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—