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510(k) Data Aggregation

    K Number
    K151255
    Device Name
    Navigator Aesthetic Delivery System
    Date Cleared
    2015-12-30

    (232 days)

    Product Code
    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™ AE is an infiltration pump used with the Cellfina handpiece to cause a flow of dilute Lidocaine from a bag for subcutaneous delivery of anesthetic in a manner controlled manually by a healthcare professional. The Navigator is not intended for use as an IV infusion pump.
    Device Description
    The Navigator AE is an optional fluid delivery mechanism for use with the Cellfina Aesthetic handpiece. The device is comprised of the following major components: (1) a fluid delivery module (pump drive unit); (2) a disposable cassette that is designed for single use; and, (3) a wired USB foot pedal. The Navigator AE components interface with a commercially available single-use handpiece and tubing set that is discarded following use on a specific patient.
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    K Number
    K120830
    Device Name
    NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
    Date Cleared
    2012-04-16

    (28 days)

    Product Code
    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 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.
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    K Number
    K112067
    Device Name
    NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
    Date Cleared
    2011-09-16

    (59 days)

    Product Code
    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 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. Qualified ultrasound imaging units include the SonoSite M-Turbo and SonoSite M-MSK, (configuration part numbers L05323 and L05600, respectively).
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    K Number
    K101194
    Device Name
    NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
    Date Cleared
    2011-07-11

    (439 days)

    Product Code
    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 device consists of a fluid delivery module (motor driven piston syringe pump), a daily disposable cassette, a per-patient disposable handpiece and tubing set. and a wired foot pedal. The fluid delivery module delivers the medications or fluids from off-the-shelf vials via aspirated dispense. The user interface is via touch screen that allows the user to define per-delivery treatment volumes and regimens of off-the-shelf medications or fluids in accordance with their labeled indication and proposed dosage. Delivery of the user-defined regimen occurs through depression of the foot pedal that actuates dispense of the fluids through three individual fluid lines within the cassette. The fluid is then transported through the per-patient tubing and handpiece set where off-the-shelf needles are attached.
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