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

    SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS

    K Number: K993667 · Decision Jan 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
    K Number
    K993667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzermedica
    Date Received
    November 1, 1999
    Decision Date
    January 28, 2000
    Product Code
    DSY
    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
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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    Other Clearances by Sulzermedica

    K Number Device Name
    K002324 MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
    K990503 SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
    K993569 APR METASUL ACETABULAR INSERT
    K992832 SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS