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510(k) Data Aggregation

    K Number
    K961777
    Date Cleared
    1996-07-31

    (85 days)

    Product Code
    Regulation Number
    870.1330
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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