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510(k) Data Aggregation

    K Number
    K250747
    Device Name
    Globe® Pulsed Field System
    Manufacturer
    Kardium Inc.
    Date Cleared
    2025-06-25

    (105 days)

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

    Kardium Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Globe PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.
    Device Description
    The Globe Pulsed Field System (Globe PF System) comprises the following components and accessories to support anatomical and electrophysiological mapping, and pacing stimulation of cardiac tissue: • **Globe Controller:** Used for the acquisition and processing of signals for cardiac anatomical and electrophysiological mapping, generation of mapping energy and stimulation pulses. • **Globe Workstation:** A PC workstation configured with the Globe Software, which the clinician uses to assess contact between the mapping catheter electrodes and the atrial wall, map the atrial electrical activity, and apply stimulation pulses for diagnostic purposes. • **Globe Positioning System (GPS™) Electrodes and GPS Cable:** Surface electrodes and cables for localization of the mapping catheter.
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    K Number
    K250529
    Device Name
    Globe Introducer (601-01001)
    Manufacturer
    Kardium Inc.
    Date Cleared
    2025-06-03

    (99 days)

    Product Code
    DRA
    Regulation Number
    870.1280
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kardium Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The Globe® Introducer is a single use, ethylene oxide sterilized medical device used to facilitate percutaneous access to the vasculature and into the heart chambers. The device consists of a 16 Fr (5.3 mm) inner diameter (ID) steerable sheath with a hydrophilic coating, a dilator compatible with 0.89 mm (0.035 in) guidewires, and a dilator loader. The proximal end of the sheath includes a handle with an integrated steering knob for bidirectional deflection control of the sheath tip, a steering indicator, and a slider. The slider contains a loader connection port for the dilator loader and a compatible catheter loader. The slider provides a hemostatic seal and a saline flushing line with a standard Luer fitting stopcock, for air removal and management.
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