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

    ATLANTIS PV

    K Number: K050684 · Decision May 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    432
    Review Days
    64

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    Basic Information

    Device Name
    ATLANTIS PV
    K Number
    K050684
    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 Corp
    Date Received
    March 17, 2005
    Decision Date
    May 20, 2005
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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