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510(k) Data Aggregation

    K Number
    K160390
    Device Name
    Map-it Diagnostic Mapping Catheters
    Manufacturer
    ACCESS POINT TECHNOLOGIES EP, INC.
    Date Cleared
    2016-04-11

    (60 days)

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

    ACCESS POINT TECHNOLOGIES EP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
    Device Description
    The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient's heart. They are available in fixed curve and steerable configurations. The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies. The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle.
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