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

    MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH

    K Number: K872154 · Decision Aug 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    15
    Review Days
    63

    Basic Information

    Device Name
    MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH
    K Number
    K872154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    IDEAS FOR MEDICINE, INC.
    Date Received
    June 1, 1987
    Decision Date
    August 3, 1987
    Product Code
    DQT
    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
    DQT Occluder, Catheter Tip

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