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510(k) Data Aggregation

    K Number
    K024019
    Device Name
    ARTERIALFLOW SYSTEM, MODEL 32A
    Manufacturer
    AIRCAST, INC.
    Date Cleared
    2003-06-03

    (180 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARTERIALFLOW SYSTEM, MODEL 32A

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

    For the improvement of blood circulation in the upper and lower extremities to help prevent and reduce complications of poor circulation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, and device performance for the Arterialflow System, Model 32A. The document is an FDA 510(k) clearance letter, which primarily deals with the regulatory approval of the device based on its substantial equivalence to a predicate device. It indicates that the device can be legally marketed but does not provide details about performance studies or acceptance criteria that would typically be found in a clinical trial report or a summary of safety and effectiveness data.

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