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510(k) Data Aggregation

    K Number
    K971775
    Device Name
    INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
    Date Cleared
    1997-12-29

    (230 days)

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

    CARDIAC CONTROL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers.
    Device Description
    The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter. The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting.
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