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510(k) Data Aggregation

    K Number
    K102940
    Device Name
    VASCOPRESS SEQUENTIAL DVT PUMP
    Manufacturer
    COMPRESSION THERAPY CONCEPTS
    Date Cleared
    2011-01-20

    (108 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    The VasoPress Sequential DVT Pump is an external pneumatic compression device for use with VasoPress Sequential Garments.

    AI/ML Overview

    The provided documents are a letter from the FDA to Compression Therapy Concepts, Inc. regarding the 510(k) premarket notification for the VasoPress Sequential DVT Pump, and the "Indications for Use Statement" for the same device. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a study report or clinical trial summary.

    Therefore, I cannot provide the requested information based on the given text. The documents confirm the device's regulatory clearance and its intended use but do not describe the scientific studies or data supporting its performance.

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