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510(k) Data Aggregation

    K Number
    K060902
    Device Name
    STARCLOSE INTRODUCER SET MODEL- 1002
    Manufacturer
    ABBOTT VASCULAR INC.
    Date Cleared
    2006-07-07

    (95 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The StarClose™ Introducer Set is intended for use in procedures requiring percutaneous introduction of intravascular devices.

    Device Description

    The StarClose™ Introducer Set consists of a 6F Introducer, a Dilator and a "J"-tip guidewire and is for use in gaining access to blood vessels for diagnostic and interventional procedures.

    AI/ML Overview

    The provided text describes the Abbott Vascular StarClose Introducer Set (K060902) but does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than detailed clinical performance studies with specific acceptance criteria.

    Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The information you are seeking (acceptance criteria, device performance, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this regulatory submission document.

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