BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    TORFLEX TRANSSEPTAL GUIDING SHEATH

    K Number: K013919 · Decision Feb 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    28
    Review Days
    87

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    Basic Information

    Device Name
    TORFLEX TRANSSEPTAL GUIDING SHEATH
    K Number
    K013919
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baylis Medical Co., Inc.
    Date Received
    November 27, 2001
    Decision Date
    February 22, 2002
    Product Code
    DBY
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DBY Fab, Rhodamine, Antigen, Antiserum, Control

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