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

    NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

    K Number: K153479 · Decision Feb 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    45
    Applicant Total
    8
    Review Days
    76

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    Basic Information

    Device Name
    NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
    K Number
    K153479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Ninepoint Medical, Inc.
    Date Received
    December 2, 2015
    Decision Date
    February 16, 2016
    Product Code
    NQQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NQQ System, Imaging, Optical Coherence Tomography (Oct)

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    Other Clearances by Ninepoint Medical, Inc.

    K Number Device Name
    K191117 NvisionVLE Low-profile Optical Probe
    K182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
    K182261 NvisionVLE Imaging System, NvisionVLE Optical Probe
    K143678 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
    K120800 NVISION VLE IMAGING SYSTEM
    K121195 NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
    K112770 NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER