510(k) Report

Devices descending from K120212

5 later devices reach Afx Introducer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+2K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+3K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+3K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+4K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—