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

    DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS

    K Number: K860867 · Decision Jul 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    213
    Registration Numbers
    214
    Same Product Code
    497
    Applicant Total
    46
    Review Days
    117

    Basic Information

    Device Name
    DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS
    K Number
    K860867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    MEDICAL COMPONENTS, INC.
    Date Received
    March 7, 1986
    Decision Date
    July 2, 1986
    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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