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510(k) Data Aggregation

    K Number
    K043446
    Device Name
    EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER
    Manufacturer
    Date Cleared
    2005-02-04

    (52 days)

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

    EMMEBI SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable.
    Device Description
    The Emmebi Central Venous Catheter Kit is comprised of three main components; 1. Syringe/inserter 2. guidewire (J-Wire) and 3. central venous catheter. The catheter kit is intended for short term use as an aid to access the central venous system. The Syringe/inserter simplifies the technique used by physicians to perform catheterization. The guidewire (J-Wire) is designed to fit inside a percutaneous catheter for the purpose of directing the catheter being introduced. The catheters are available in 14-> 22 gauge sizes with 4, 5, 6 and 7 Fr. diameter sizes in either a single, double or triple lumen. Circular lumen passages have soft flexible tapered tips. Lumens are connected to extensions containing hubs and catheter fixing wings. The lumens are printed with depth markings. Catheter markings are radiopaque.
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