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

    CENTRAL VEIN CATHERIZATION KIT

    K Number: K823758 · Decision Feb 23, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    3
    Review Days
    71

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    Basic Information

    Device Name
    CENTRAL VEIN CATHERIZATION KIT
    K Number
    K823758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Access Devices, Inc.
    Date Received
    December 14, 1982
    Decision Date
    February 23, 1983
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Access Devices, Inc.

    K Number Device Name
    K823017 INTRAVENOUS CATHETER PLACEMENT UNIT &
    K822834 ACCESS PERCUTANEOUS INTRODUCER SET