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510(k) Data Aggregation

    K Number
    K180722
    Device Name
    CAPERE Thrombectomy System
    Manufacturer
    KP Medcure, Inc.
    Date Cleared
    2018-06-11

    (84 days)

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

    KP 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 consists of a 12Fr Delivery Catheter and a 20Fr Guide Catheter. The 12Fr Delivery Catheter consists of a nitinol basket that comes in two different sizes (10 mm and 18 mm). The 20Fr Guide Catheter consists of an inner and outer guide and an inner and outer introducer. The CAPERE™ Thrombectomy System is delivered percutaneously via transfernoral 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 extract thrombus but does have a side port in the guide catheter that allows aspiration or injection of saline or fluids if needed.
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