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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Admedus Regen Pty Ltd

    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
    K170951
    Device Name
    CardioCel 3D
    Manufacturer
    Admedus Regen Pty Ltd
    Date Cleared
    2017-04-28

    (28 days)

    Product Code
    PSQ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Admedus Regen Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardioCel 3D is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
    Device Description
    The CardioCel 3D 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. It is offered in a 4 x 6 cm size with a 60° curve.
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    K Number
    K162579
    Device Name
    VascuCel
    Manufacturer
    Admedus Regen Pty Ltd
    Date Cleared
    2016-10-14

    (29 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Admedus Regen Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.
    Device Description
    The VascuCel 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. It is offered in a 2 x 8 cm size and a 0.8 x 8 cm size.
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