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510(k) Data Aggregation

    K Number
    K233783
    Device Name
    exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
    Manufacturer
    PECA Labs, Inc.
    Date Cleared
    2024-01-17

    (51 days)

    Product Code
    DSY, DYF
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PECA Labs, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
    Device Description
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
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    K Number
    K221628
    Device Name
    exGraft, exGraft Carbon
    Manufacturer
    PECA Labs
    Date Cleared
    2022-08-04

    (59 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PECA Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
    Device Description
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
    Ask a Question
    K Number
    K202471
    Device Name
    exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
    Manufacturer
    PECA Labs
    Date Cleared
    2020-12-11

    (105 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PECA Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
    Device Description
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
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    K Number
    K183613
    Device Name
    exGraft, exGraft Carbon
    Manufacturer
    PECA Labs
    Date Cleared
    2019-04-22

    (117 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PECA Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
    Device Description
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
    Ask a Question
    K Number
    K180957
    Device Name
    exGraft, exGraft Carbon ePTFE Vascular Grafts
    Manufacturer
    PECA Labs
    Date Cleared
    2018-08-21

    (131 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PECA Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
    Device Description
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the outer surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
    Ask a Question

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