BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GORE-TEX TUNNELER

    K Number: K844584 · Decision Jan 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    70
    Applicant Total
    127
    Review Days
    62

    Basic Information

    Device Name
    GORE-TEX TUNNELER
    K Number
    K844584
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    W.L. GORE & ASSOCIATES,INC
    Date Received
    November 23, 1984
    Decision Date
    January 24, 1985
    Product Code
    DWS
    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
    DWS Instruments, Surgical, Cardiovascular

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    K083266 GORE BIO-A FISTULA PLUG
    K083300 GORE FLOW REVERSAL SYSTEM
    K081069 GORE INFINIT MESH
    K062161 GORE PROPATEN VASCULAR GRAFT
    K061727 GORE PRECLUDE VESSEL GUARD
    K053200 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
    K043056 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
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