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510(k) Data Aggregation

    K Number
    K010330
    Device Name
    ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
    Manufacturer
    ARROW INTL., INC.
    Date Cleared
    2001-03-02

    (28 days)

    Product Code
    DSP
    Regulation Number
    870.3535
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arrow Rediguard® 9Fr. 50cc Intra-Aortic Balloon Catheters IAB-R950-U is clinically indicated for the following conditions:
    a. Acute Coronary Syndrome
    b. Cardiac and Non-Cardiac Surgery
    c. Complications of Heart Failure

    Device Description

    The device is a dual lumen perculaneously inserted Intra-Aortic IAB catheter, 9 Fr. in size, with two independent non-communicating lumens. The outer lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. The IAB is timed to inflate in the aorta during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart. resulting in increased blood supply to the heart muscle arid decreased work load for the left ventricle. The Arrow RediGuard® catheter is available in a 9Fr. 50cc volume, and is identical in appearance and function to the predicate devices.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Arrow Rediguard® 9Fr. 50cc Intra-Aortic Balloon Catheters IAB-R950-U) and not a clinical study report.

    Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of a multi-reader multi-case study.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices, listing indications for use, and describing the device's technical characteristics for regulatory approval purposes. It mentions "laboratory tests" but does not detail their methodology, acceptance criteria, or results in the context of human reader performance or AI capabilities.

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