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Ninepoint Medical, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest Approval2019-07-19
TypeNumberDevice NameCodeDate
510(k) K191117 NvisionVLE Low-profile Optical Probe NQQ 2019-07-19 View
510(k) K182616 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System NQQ 2018-11-02 View
510(k) K182261 NvisionVLE Imaging System, NvisionVLE Optical Probe NQQ 2018-10-16 View
510(k) K153479 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System NQQ 2016-02-16 View