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510(k) Data Aggregation

    K Number
    K972065
    Device Name
    AURORA
    Manufacturer
    NEUROVENA CORP.
    Date Cleared
    1999-01-27

    (603 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROVENA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.
    Device Description
    The AURORA is a single lumen radiopaque catheter with a proximal Luer fitting. The AURORA is pakaged sterile and is intended for single use only.
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