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

    ALBOGRAFT VASCULAR PROSTHESIS

    K Number: K093231 · Decision Jan 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    32
    Review Days
    92

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    Basic Information

    Device Name
    ALBOGRAFT VASCULAR PROSTHESIS
    K Number
    K093231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    LeMaitre Vascular, Inc.
    Date Received
    October 14, 2009
    Decision Date
    January 14, 2010
    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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