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

    HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT

    K Number: K954848 · Decision Feb 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    53
    Review Days
    101

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    Basic Information

    Device Name
    HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
    K Number
    K954848
    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
    October 23, 1995
    Decision Date
    February 1, 1996
    Product Code
    MAL
    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
    MAL Graft, Vascular, Synthetic/Biologic Composite

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