510(k) Report

Devices descending from K011210

13 later devices reach The Percuquick Set for Percutaneous Dilation Tracheostomy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical200451
+1K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc.200317
+1K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited200310—
+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—
+2K050166Portex Emergency Cricothyroidotomy KitSmiths Medical20050—
+2K041044Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc.20042—
+2K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd.20046—
+3K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…Cook Incorporated20190Class I
+3K180034Weinmann Tracheostomy Exchange SetCook Incorporated20181—
+3K072148Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy IntroducerCook, Inc.20071—
+4K093469Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple…Cook, Inc.2010017