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    K Number
    K971498
    Device Name
    APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Date Cleared
    1997-05-05

    (10 days)

    Product Code
    EZB
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    EZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.
    Device Description
    The Applied Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowing ease of access and visibility during placement. Differences include a change of indicated use and a selection of different lengths.
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    K Number
    K970994
    Device Name
    CORE AND COIL ASSEMBLY GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    1997-03-25

    (6 days)

    Product Code
    EZB
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    EZB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters: Outside Diameter: .014" - . 045" Length: 20 cm - 500 cm Tip: Straight, Shapable or Preshaped Flexibility: Soft through Stiff Coil Length: 2 cm - 30 cm NOTE: None of these guidewires are for PTCA use.
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