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

    Steerable catheter control system

    K Number: K183027 · Decision Sep 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    28
    Review Days
    309

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    Basic Information

    Device Name
    Steerable catheter control system
    K Number
    K183027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stereotaxis, Inc.
    Date Received
    November 1, 2018
    Decision Date
    September 6, 2019
    Product Code
    PJB
    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
    PJB Catheter Remote Control System

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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
    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
    K122659 VDRIVE W/V-SONO
    Search all 28 clearances from Stereotaxis, Inc. →