BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite

    PMA: P800064 · Decision Mar 10, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite
    Trade Name
    BIOFLOW(TM)
    PMA Number
    P800064
    Device Class
    FDA Class 3
    Product Code
    MCI
    Generic Name
    Graft, vascular, hemodialysis access, synthetic/biological composite
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 1982
    Date Received
    December 1, 1980
    Expedited Review
    N
    Docket Number
    82M-0094

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCI Graft, Vascular, Hemodialysis Access, Synthetic/Biological Composite