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510(k) Data Aggregation

    K Number
    K124053
    Device Name
    NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
    Manufacturer
    CARTICEPT MEDICAL, INC.
    Date Cleared
    2013-03-13

    (72 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARTICEPT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.
    Device Description
    The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a disposable cassette, a reusable cassette housing, disposable vial clamps, per-patient disposable handpiece and tubing, and wired foot pedal. Image integration with qualified ultrasound units occurs by Ethernet cable connection, if desired, allowing simultaneous display of Navigator treatment information on the ultrasound screen and printing of ultrasound images on the patient treatment record.
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    K Number
    K122215
    Device Name
    NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
    Manufacturer
    CARTICEPT MEDICAL, INC.
    Date Cleared
    2012-10-26

    (93 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARTICEPT MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NavigatorTM Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.
    Device Description
    The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a daily disposable cassette, a per-patient disposable handpiece and tubing set, and wired foot pedal. Image integration with qualified ultrasound units occurs by Ethernet cable connection, if desired, allowing simultaneous display of Navigator treatment information on the ultrasound screen and printing of ultrasound images on the patient treatment record.
    Ask a Question

    Ask a specific question about this device

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