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510(k) Data Aggregation

    K Number
    K251257

    Validate with FDA (Live)

    Device Name
    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
    Manufacturer
    Np Medical
    Date Cleared
    2025-12-04

    (225 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K200439
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Product Name: nSet+ Stabilization Set
    Part Number: 6426733
    The nSet+ Stabilization Set is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.

    Product Name: nSet+ Stabilization Set with nSyte Needle Free Connector (NFC)
    Part Number: 6426731
    The nSet+ Stabilization Set with nSyte needle free connector is for single use only. The nSet+ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSet+ Stabilization Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.

    Product Name: nSyte Needle Free Connector (NFC)
    Part Number: 6426727
    The nSyte needle free connector is for single use only. The nSyte needle free connector may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The nSyte needle free connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 ml per second.

    Device Description

    Product Name: nSet+ Stabilization Set
    Part Number: 6426733
    Description: The nSet+ Stabilizing Set is a sterile, single patient use, add-on medical device used in peripheral vascular access systems. The nSet+ Stabilizing Set includes a stabilization base, an extension tube, a tube pinch clamp, and terminates with locking ISO 80369-7 connectors on each end, capped. It is sold individually blister packed with fifty (50) total units per carton and is labeled with a shelf life of one year.

    Product Name: nSet+ Stabilization Set with nSyte Needle Free Connector (NFC)
    Part Number: 6426731
    Description: The nSet+ Stabilizing Set with nSyte Needle Free Connector is a sterile, single patient use, add-on medical device used in peripheral vascular access systems. The nSet+ Stabilizing Set includes a stabilization base, an extension tube, a tube pinch clamp, an nSyte Needle Free Connector, and terminates with a locking ISO 80369-7 male connector, capped. It is sold individually blister packed with fifty (50) total units per carton and is labeled with a shelf life of one year.

    Product Name: nSyte Needle Free Connector (NFC)
    Part Number: 6426727
    Description: The nSyte Needle Free Connector is a sterile, single patient use, add-on medical device used in peripheral vascular access systems.

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