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

    SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS

    K Number: K961999 · Decision Nov 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    35
    Review Days
    181

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    Basic Information

    Device Name
    SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
    K Number
    K961999
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Scimed, Inc.
    Date Received
    May 22, 1996
    Decision Date
    November 19, 1996
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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