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510(k) Data Aggregation

    K Number
    K041818
    Device Name
    SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2004-11-10

    (127 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter for the Sonicath Ultra Imaging Catheter. The document itself does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications. It merely states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from the given text.

    To answer your questions, I would need access to the full 510(k) submission, which typically includes the detailed testing and performance data.

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