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    K Number
    K962307
    Device Name
    RHYDER DIAGNOSTIC CATHETER
    Manufacturer
    FIDUS MEDICAL TECHNOLOGY CORP.
    Date Cleared
    1996-09-17

    (92 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIDUS MEDICAL TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fidus Rhyder Diagnostic Catheter is intended to simultaneously pace and record monophasic action potentials (MAPs) from the endocardial surface of the heart. The combined capabilities of this catheter obviate the need to insert a separate catheter for stimulation in MAP studies.
    Device Description
    The Fidus Rhyder Diagnostic Catheter is a flexible catheter with two pairs of electrodes at the distal tip. One pair of electrodes consisting of tip (active) and side (indifferent) electrodes is used for recording ECG signals. The second pair of electrodes, located adjacent to the catheter's tip, are used for pacing. The Rhyder Diagnostic Catheter is available with three distal tip designs.
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