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

    VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM

    K Number: K012544 · Decision Nov 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    5
    Review Days
    100

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    Basic Information

    Device Name
    VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
    K Number
    K012544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Architects, Inc.
    Date Received
    August 7, 2001
    Decision Date
    November 15, 2001
    Product Code
    JCT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JCT Prosthesis, Tracheal, Expandable

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    Other Clearances by Vascular Architects, Inc.

    K Number Device Name
    K031641 VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM
    K030567 MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
    K003173 ASPIRE COVERED STENT AND DELIVERY CATHETER
    K003719 VASCULAR ARCHITECTS PERISCOPE DEVICE