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

    STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

    K Number: K021555 · Decision Jan 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    32
    Applicant Total
    28
    Review Days
    247

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    Basic Information

    Device Name
    STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
    K Number
    K021555
    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
    May 13, 2002
    Decision Date
    January 15, 2003
    Product Code
    DXX
    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
    DXX System, Catheter Control, Steerable

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    Other Clearances by Stereotaxis, Inc.

    K Number Device Name
    K253473 Synchrony
    K251792 Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
    K250590 MAGiC Sweep™ EP Mapping Catheter
    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. →