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

    ATRIUM'S HYBRID PTFE

    K Number: K933391 · Decision Dec 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    63
    Review Days
    521

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    Basic Information

    Device Name
    ATRIUM'S HYBRID PTFE
    K Number
    K933391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Atrium Medical Corp.
    Date Received
    July 12, 1993
    Decision Date
    December 15, 1994
    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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