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

    PRUITT SAFETY OCCLUSION CATHETER

    K Number: K960422 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    15
    Review Days
    191

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    Basic Information

    Device Name
    PRUITT SAFETY OCCLUSION CATHETER
    K Number
    K960422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ideas For Medicine, Inc.
    Date Received
    January 29, 1996
    Decision Date
    August 7, 1996
    Product Code
    MJN
    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
    MJN Catheter, Intravascular Occluding, Temporary

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