510(k) Report

Devices descending from K093111

6 later devices reach Mikro-Cath, Model 825-0101 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163376Mikro-Cath Pressure CatheterMillar, Inc.20170—
+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—