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510(k) Data Aggregation

    K Number
    K061680
    Device Name
    ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2006-12-15

    (183 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Atrium ClearWay™ RX Catheter is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Atrium ClearWay™ RX Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information. The text is limited to regulatory clearance and does not delve into the technical validation or performance studies of the device.

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