BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOSENSORS CENTRAL VENOUS CATHETER KITS

    K Number: K002786 · Decision Nov 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    BIOSENSORS CENTRAL VENOUS CATHETER KITS
    K Number
    K002786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunscope Intl., Inc.
    Date Received
    September 7, 2000
    Decision Date
    November 17, 2000
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Sunscope Intl., Inc.

    K Number Device Name
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    K981747 BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
    K981745 BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
    K911710 HEPARIN COATED THERMODILUTION CATH & ACCESSORIES
    K912172 SAFEWEDGE(TM) RELIEF VALVE DEVICE