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510(k) Data Aggregation

    K Number
    K150303
    Device Name
    XXL Vascular Balloon Dilatation Catheter
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2015-06-15

    (129 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XXL Vascular Balloon Dilatation Catheter

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Boston Scientific Corporation's XXL Vascular Balloon Dilatation Catheter. It states that the device has been found substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of any clinical studies (such as MRMC or standalone studies).

    Therefore, I cannot extract the requested information from this document. The letter merely communicates the FDA's regulatory decision and outlines ongoing responsibilities for the manufacturer.

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