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

    CENTRAL VENOUS ACCESS CATHETER CVAC

    K Number: K832396 · Decision Aug 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    75
    Review Days
    42

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    Basic Information

    Device Name
    CENTRAL VENOUS ACCESS CATHETER CVAC
    K Number
    K832396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Gish Biomedical, Inc.
    Date Received
    July 20, 1983
    Decision Date
    August 31, 1983
    Product Code
    DOY
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DOY Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

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