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510(k) Data Aggregation

    K Number
    K041727
    Device Name
    MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
    Manufacturer
    BOSTON SCIENTIFIC SCIMED, INC.
    Date Cleared
    2004-07-23

    (28 days)

    Product Code
    OBJ
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456

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

    The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Atlantis PV Imaging Catheter" and focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details on acceptance criteria, a specific study proving device performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device as outlined in your prompt.

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