510(k) Report

Devices descending from K880247

7 later devices reach Modified Shiley Low Pressure Cuffed Tracheo. Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical200451
+1K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc.200301
+2K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous…Smiths Medical Asd, Inc.20180Class I
+2K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc.201421
+2K083031Portex Uniperc Percutaneous Dilation Tracheostomy KitSmiths Medical Asd, Inc.20090—
+3K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated20190Class I
+3K180034Weinmann Tracheostomy Exchange SetCook Incorporated20181—