510(k) Report

Devices descending from K160272

3 later devices reach Endophys Pressure Sensing Sheath Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+1K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+2K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—