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510(k) Data Aggregation

    K Number
    K203476
    Device Name
    CAPERE Thrombectomy System
    Manufacturer
    Vascular Medcure, INC.
    Date Cleared
    2020-12-22

    (27 days)

    Product Code
    QEW, KRA, OEW
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Medcure, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPERE® Thrombectomy System is indicated for: - Non-surgical removal of soft emboli and thrombi from blood vessels. - Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
    Device Description
    The CAPERE® Thrombectomy System primarily consists of a Delivery Catheter and Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
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    K Number
    K201216
    Device Name
    CAPERE Thrombectomy System
    Manufacturer
    Vascular Medcure, Inc.
    Date Cleared
    2020-07-08

    (64 days)

    Product Code
    QEW, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Medcure, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPERE® Thrombectomy System is indicated for: -Non-surgical removal of soft emboli and thrombi from blood vessels. -Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
    Device Description
    The CAPERE® Thrombectomy System primarily consists of an 9Fr Delivery Catheter and 12Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
    Ask a Question
    K Number
    K200314
    Device Name
    Capere Thrombectomy System
    Manufacturer
    Vascular Medcure, Inc.
    Date Cleared
    2020-03-04

    (27 days)

    Product Code
    QEW, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Medcure, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPERE® Thrombectomy System is indicated for: - Non-surgical removal of soft emboli and thrombi from blood vessels. - Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
    Device Description
    The CAPERE® Thrombectomy System primarily consists of an 12Fr Delivery Catheter and 15Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
    Ask a Question
    K Number
    K192935
    Device Name
    CAPERE Thrombectomy System
    Manufacturer
    Vascular Medcure, Inc.
    Date Cleared
    2019-11-15

    (29 days)

    Product Code
    QEW, QEY
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Medcure, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPERE® Thrombectomy System is indicated for: - Non-surgical removal of soft emboli and thrombi from blood vessels. - Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
    Device Description
    The CAPERE® Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
    Ask a Question
    K Number
    K183179
    Device Name
    CAPERE Thrombectomy System
    Manufacturer
    Vascular Medcure, Inc.
    Date Cleared
    2019-02-25

    (101 days)

    Product Code
    QEW, DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Medcure, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAPERE™ Thrombectomy System is indicated for: · Non-surgical removal of soft emboli and thrombi from blood vessels. - · Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
    Device Description
    The CAPERE™ Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE™ Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
    Ask a Question

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