510(k) Report

Devices descending from K120997

7 later devices reach Barostat Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160725EndoFLIPCrospon, Ltd.20164—
+1K132337Esoflip Balloon Dilation CatheterCrospon, Ltd.201301
+1K130906Endoflip CatheterCrospon, Ltd.20130—
+2K183072EndoFLIP SystemCrospon, Ltd.201921
+2K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd.20170—
+3K223705EndoflipTM 300Covidien, LLC20231—
+4K231861EndoflipTM 300 SystemCovidien, LLC20230—