BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

    K Number: K960766 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    53
    Review Days
    387

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    Basic Information

    Device Name
    MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
    K Number
    K960766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Meadox Medicals, Div. Boston Scientific Corp.
    Date Received
    February 26, 1996
    Decision Date
    March 19, 1997
    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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