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510(k) Data Aggregation

    K Number
    K961763
    Device Name
    PULSE*SPRAY INFUSION SYSTEM
    Manufacturer
    ANGIODYNAMICS, DIV. E-Z-EM, INC.
    Date Cleared
    1996-07-17

    (71 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIODYNAMICS, DIV. E-Z-EM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulse*Spray ® System, PRO™ Infusion Catheter, and its related components, are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics and contrast media, into the peripheral vasculature.
    Device Description
    Not Found
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