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510(k) Data Aggregation

    K Number
    K991038
    Device Name
    VASO PRESS DVT SYSTEM, MODELS VP500, VP501
    Manufacturer
    BRITT CORP., INC.
    Date Cleared
    2000-06-22

    (451 days)

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

    VASO PRESS DVT SYSTEM, MODELS VP500, VP501

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

    The Vaso Press system is an external pneumatic compression system intended to lower the risk of deep vein thrombosis (DVT) in patients whom may be at risk

    Device Description

    Vaso Press DVT System, Pump Model VP 500 and Sleeve Model VP 501

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is a 510(k) summary and approval letter, which primarily focuses on the regulatory aspects of device clearance rather than the detailed performance testing and validation studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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