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510(k) Data Aggregation

    K Number
    K032613
    Device Name
    TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
    Manufacturer
    PETER M. ROTHENBERG, M.D.
    Date Cleared
    2003-11-20

    (87 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PETER M. ROTHENBERG, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind and designed to isolate the proximal electrode from inadvertent stimulation.
    Device Description
    In essence, the subject device provides an electrically safe connection between the proximal pin of an intravascular electrode and a patient EKG lead , the signal ultimately traveling retrograde along a standard EKG cable to a bedside monitor. It would be used to facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance rather than the more cumbersome (and expensive) fluoroscopic approach. The device entirely consists of a pin jack (to accept the proximal pin of the electrode) connected in series via a 1000 ohm resistor to a standard EKG eyelet all encased in an appropriate housing. The snap-fit connection between the EKG lead and device eyelet completes the connection to the monitor.
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