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510(k) Data Aggregation

    K Number
    K012089
    Device Name
    CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
    Manufacturer
    CATHEFFECTS, LLC.
    Date Cleared
    2002-01-28

    (207 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHEFFECTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CATHEFFECTS Desai VectorCath™ Mapping System is intended to aid in the determination and analysis of abnormal heart activity. The device is used in conjunction with a 5-electrode catheter to record endocardial potentials to aid in the determination of the direction of the cardiac wavefront and the possible location of the wavefront's source.
    Device Description
    Not Found
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    K Number
    K011361
    Device Name
    DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
    Manufacturer
    CATHEFFECTS, LLC.
    Date Cleared
    2001-09-06

    (126 days)

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

    CATHEFFECTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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