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510(k) Data Aggregation

    K Number
    K971619
    Device Name
    MICROFUSE MEMBRANE INFUSION CATHETER
    Manufacturer
    E-MED CORP.
    Date Cleared
    1998-02-27

    (302 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    E-MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    e Med's Microfuse Membrane Infusion Catheter is a nondilatation over-the-wire device intended for the localized infusion of therapeutic solution(s) in the coronary vasculature through a microporous membrane. The catheter is intended to be coaxially tracked over a guidewire to access a subselective infusion region in the coronary vasculature. The technique, rate of administration, duration of infusion, and appropriate sizing of the membrane to the arterial diameter is determined by the operating physician. The infusion solution should be used in accordance with the manufacturer's instructions for use.
    Device Description
    The Microfuse Membrane Infusion Catheter is a non-dilatation, over-thewire infusion device designed for localized delivery of solutions through a microporous membrane. The membrane gently "sweats" solution through its many pores. The device can accommodate a coronary guidewire.
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