510(k) Report

Devices descending from K153479

2 later devices reach NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+2K251730LIA Console (542-7)Leadoptik, Inc.20250—