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510(k) Data Aggregation

    K Number
    K101915
    Device Name
    VASOPRESS SUPREME MINI MODEL VP500DM
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Date Cleared
    2010-08-06

    (28 days)

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

    VASOPRESS SUPREME MINI MODEL VP500DM

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

    The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.

    Device Description

    VasoPress DVT Supreme Mini, Pump Model No. VP500DM

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is a 510(k) premarket notification letter from the FDA to Compression Therapy Concepts regarding the VasoPress DVT Supreme Mini pump. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices for the indication of lowering the risk of deep vein thrombosis (DVT). It also outlines regulatory requirements but does not include any performance study details.

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