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510(k) Data Aggregation

    K Number
    K130518
    Device Name
    MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
    Manufacturer
    LUTHER NEEDLESAFE PRODUCTS, INC.
    Date Cleared
    2013-04-30

    (62 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUTHER NEEDLESAFE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.
    Device Description
    The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.
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    K Number
    K040527
    Device Name
    LOW PROFILE LUTHER SAFETY HUBER
    Manufacturer
    LUTHER NEEDLESAFE PRODUCTS, INC.
    Date Cleared
    2004-03-26

    (25 days)

    Product Code
    FPA, REQ
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUTHER NEEDLESAFE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
    Device Description
    The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials, The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.
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