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510(k) Data Aggregation

    K Number
    K213584
    Device Name
    Reprocessed NRG Transseptal Needle
    Manufacturer
    Innovative Health, LLC.
    Date Cleared
    2023-04-04

    (508 days)

    Product Code
    QLZ, OLZ, REP
    Regulation Number
    870.5175
    Why did this record match?
    Product Code :

    QLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
    Device Description
    The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and optionally to an external pressure monitoring system via a luer connection. The dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
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    K Number
    K200060
    Device Name
    Reprocessed NRG Transseptal Needle
    Manufacturer
    Innovative Health, LLC.
    Date Cleared
    2020-07-30

    (199 days)

    Product Code
    QLZ, OLZ
    Regulation Number
    870.5175
    Why did this record match?
    Product Code :

    QLZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
    Device Description
    The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and, optionally, to an external pressure monitoring system via a luer connection. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. The active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.
    Ask a Question

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