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

    PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451

    K Number: K984183 · Decision Feb 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    34
    Review Days
    70

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    Basic Information

    Device Name
    PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
    K Number
    K984183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Possis Medical, Inc.
    Date Received
    November 23, 1998
    Decision Date
    February 1, 1999
    Product Code
    DYF
    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
    DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

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