510(k) Report

Devices descending from K991288

12 later devices reach Distender Series II Barostat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160287Rapid Barostat Bag (RBB) Pump and CatheterMui Scientific20171—
+1K160725EndoFLIPCrospon, Ltd.20164—
+1K120997Barostat Software OptionCrospon, Ltd.20127—
+1K092850EndoflipCrospon, Ltd.20099—
+2K262621Rapid Barostat Bag (RBB) Pump and Catheter SystemMui Scientific, Inc.20260—
+2K183072EndoFLIP SystemCrospon, Ltd.201921
+2K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd.20170—
+2K132337Esoflip Balloon Dilation CatheterCrospon, Ltd.201301
+2K130906Endoflip CatheterCrospon, Ltd.20130—
+2K102214Endo FlipCrospon, Ltd.20101—
+3K223705EndoflipTM 300Covidien, LLC20231—
+4K231861EndoflipTM 300 SystemCovidien, LLC20230—