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510(k) Data Aggregation

    K Number
    K121859
    Device Name
    TYSHAK NUCLEUS
    Manufacturer
    NUMED, INC.
    Date Cleared
    2012-08-31

    (66 days)

    Product Code
    DQY,DOY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TYSHAK NUCLEUS

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

    This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

    • A patient with isolated pulmonary stenosis.
    • A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the NuMED Inc. Tyshak NuCLEUS™ Catheter, which primarily addresses regulatory classification and substantial equivalence to predicate devices, along with indications for use. It does not include details on performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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