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510(k) Data Aggregation

    K Number
    K240775
    Device Name
    PeriBeam® Pericardial Membrane
    Manufacturer
    TamaBio
    Date Cleared
    2025-04-18

    (393 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.
    Device Description
    PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. This device is intended for use as a temporary or permanent prosthesis for repair of pericardium
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    K Number
    K221029
    Device Name
    PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
    Manufacturer
    Synovis Life Technologies, Inc.
    Date Cleared
    2022-10-19

    (195 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing. SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
    Device Description
    PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F). PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. PERI-GUARD and SUPPLE PERI-GUARD are MR Safe. PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.
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    K Number
    K221032
    Device Name
    Vascu-Guard Vascular Repair Patch
    Manufacturer
    Synovis Life Technologies, Inc.
    Date Cleared
    2022-10-19

    (195 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.
    Device Description
    VASCU-GUARD Vascular Repair Patch (VASCU-GUARD) is derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25° (68-77°F). VASCU-GUARD is terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. VASCU-GUARD is MR Safe. VASCU-GUARD utilizes animal tissue; patient must be informed prior to any procedure.
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    K Number
    K210331
    Device Name
    CardiaMend Pericardial and Epicardial Reconstruction Matrix
    Manufacturer
    Helios Cardio Inc.
    Date Cleared
    2021-12-21

    (319 days)

    Product Code
    PSQ, PSO
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
    Device Description
    CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers. The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs.
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    K Number
    K200955
    Device Name
    Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
    Manufacturer
    Vascutek Ltd
    Date Cleared
    2020-07-08

    (90 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vascutek Cardiovascular Fabric is indicated for vascular repair whenever knitted polyester fabrics are normally indicated. Due to its particularly high strength. Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft makes it ideal for peripheral use. The Thin Wall fabric is designed for endaterectorny, particularly of the carotid arteries.
    Device Description
    The Vascutek Cardiovascular Fabric are a range of gelatin sealed, knitted, polyester patch fabrics. The range consists of three different patch fabrics which are manufactured using identical materials, processes and procedures but which, because of slight differences in the pattern of the base fabric, exhibit different physical characteristics. This range of products is provided in order to give the implanting surgeon a choice of several different fabrics from which they can chose the most suitable according to their own preferences and according to specific demands of any given surgical situation. Two of the patches, Gelseal™ and Gelsoft™, are based on fabrics which are currently used in Vascutek's range of tubular vascular prostheses, which have received Premarket approval from the FDA. The only difference between the cardiovascular fabrics and the tubular grafts is that the patches are produced in flat, patch formats (i.e. square or rectangular) and have not been subjected to the crimping process which is used in the production of the tubular prostheses. With this single exception, the manufacturing facilities, equipment, processes and the quality control processes and procedures are identical to those used in the manufacture of the Gelseal™ and Gelsoft™ vascular prostheses. The third type of patch, the Thin Wall Carotid Patch, is also manufactured using the identical materials, processes and procedures as the other cardiovascular patches but with a slightly modified knit pattern. This new structure has been developed in order to maintain the physical characteristics necessary for general cardiovascular patching but with a reduced wall thickness and characteristics which make it ideally suited to use for parching carotid arteries after endarterectomy procedures.
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    K Number
    K200566
    Device Name
    ADAPT Tissue
    Manufacturer
    Admedus Regen Pty Ltd
    Date Cleared
    2020-04-03

    (30 days)

    Product Code
    DXZ, PSQ
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADAPT® Tissue is indicated for use as a patch in the repair of cardiac defects including intracardiac defects, septal defects, valve and annulus repair.
    Device Description
    The ADAPT® Tissue medical device is a bovine pericardial patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut sheet of acellular collagen. The products range in size from 4cm² to 84cm² and can range in thickness from 0.25-0.80mm.
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    K Number
    K190882
    Device Name
    XenoSure Biologic Patch
    Manufacturer
    LeMaitre Vascular
    Date Cleared
    2020-02-13

    (315 days)

    Product Code
    PSQ, FTM, MFX
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
    Device Description
    The XenoSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. XenoSure patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution.
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    K Number
    K190884
    Device Name
    TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
    Manufacturer
    Datascope Corp.
    Date Cleared
    2019-12-26

    (266 days)

    Product Code
    GDW, FTL
    Regulation Number
    878.4750
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
    Device Description
    The TigerPaw Pro is a flexible, implantable occlusion fastener to be placed on the ostium of the left atrial appendage (LAA) during open cardiac surgical procedures. TigerPaw Pro consists of a Fastener implant that is pre-loaded onto a Delivery Tool and is for single use only. It is designed to provide an alternative to conventional suture and surgical staplers for occlusion of the ostium of the LAA. The TigerPaw Pro implantable fastener comes in two lengths; 35mm and 45mm. Surgeon judgment based on patient anatomy should determine what length fastener to apply.
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    K Number
    K191734
    Device Name
    MatriStem UBM Pericardial Patch
    Manufacturer
    Acell, Inc.
    Date Cleared
    2019-11-22

    (147 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MatriStem UBM™ Pericardial Patch is intended for the reconstruction and repair of the pericardium.
    Device Description
    The MatriStem UBM Pericardial Patch is a 4-layer multi-laminate device comprised of stacked urinary bladder matrix (UBM) sheets. The Pericardial Patch serves as a patch to reconstruct the pericardium and restore the native anatomy. The Pericardial Patch is available in three sizes: 7x10 cm, 7x15 cm, and 10x15 cm. Each device is packaged in a double peel-open pouch and an outer carton. The device is terminally sterilized using electron-beam irradiation.
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    K Number
    K183635
    Device Name
    PhotoFix Decellularized Bovine Pericardium
    Manufacturer
    CryoLife, Inc.
    Date Cleared
    2019-02-14

    (50 days)

    Product Code
    PSQ, PSO
    Regulation Number
    870.3470
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).
    Device Description
    The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.
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