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

    NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

    K Number: K060967 · Decision Oct 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    28
    Review Days
    195

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    Basic Information

    Device Name
    NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
    K Number
    K060967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stereotaxis, Inc.
    Date Received
    April 7, 2006
    Decision Date
    October 19, 2006
    Product Code
    NDQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NDQ System, Catheter Or Guidewire, Steerable (Magnetic)

    Similar 510(k) Clearances

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    Other Clearances by Stereotaxis, Inc.

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    K193147 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
    K192775 Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
    K183027 Steerable catheter control system
    K150312 Vdrive system, Vdrive Duo, Vdrive with V-Sono
    K141530 VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
    K140804 VDRIVE WITH V-LOOP/ VDRIVE DUO
    K133396 VDRIVE WITH V-SONO
    Search all 28 clearances from Stereotaxis, Inc. →