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

    MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456

    K Number: K041727 · Decision Jul 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    35
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
    K Number
    K041727
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Boston Scientific Scimed, Inc.
    Date Received
    June 25, 2004
    Decision Date
    July 23, 2004
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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