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

    MODIFICATION TO GUARDDOG OCCLUSION SYSTEM

    K Number: K062220 · Decision Aug 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    34
    Review Days
    9

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    Basic Information

    Device Name
    MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
    K Number
    K062220
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Possis Medical, Inc.
    Date Received
    August 2, 2006
    Decision Date
    August 11, 2006
    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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    K081989 MODIFICATION TO FETCH ASPIRATION CATHETER
    K081454 GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
    K080806 ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
    K073441 ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
    K072769 ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS
    K072269 ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
    Search all 34 clearances from Possis Medical, Inc. →