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510(k) Data Aggregation

    K Number
    K061678
    Device Name
    PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25
    Manufacturer
    Date Cleared
    2007-01-12

    (211 days)

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

    PRORHYTHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ProRhythm™, Inc. ProMap Coaxial Mapping Catheter is an intracardiac electrophysiology recording catheter. The ProMap is designed to be used to record cardiac electrograms for the evaluation of cardiac arrhythmias from endocardial and intravascular sites during invasive cardiac electrophysiology procedures. The ProRhythm ProMap is to be used with the ProMap Connection Cable. The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from endocardial and intravascular sites. The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.
    Device Description
    ProRhythm's ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment. The device has 6 electrodes mounted at the distal end. A passive mechanism at the distal end conforms into the shape of a ring ranging from 15 to 25 mm in diameter. The electrodes are spaced either evenly. The handle at the proximal end of the device allows the device to be manipulated into position within the left atrium. A connector at the proximal end of the device enables connection to the ProMap Connection Cable. The ProMap Coaxial Mapping Catheter is designed to be inserted through a delivery sheath catheter and into the left atrium to record electro grams. The distal end extends past the delivery sheath catheter and forms into a circular ring that is optimized for use in the pulmonary veins. Electrodes mounted at the distal end and spaced uniformly along the circular ring allow recording of pulmonary vein potentials in the left atrium. The ProMap Coaxial Mapping Catheter can be withdrawn and reinserted (without excessive friction) while the delivery sheath catheter can be deflected. This enables the electro physiologist to perform other functions through the sheaths lumen, such as contrast injections to obtain venograms.
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