510(k) Report

Devices descending from K934465

10 later devices reach Dic Tracheostomy Tube and Portex Blue Line through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031057Per-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc.200317
+1K972546Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl.19982—
+1K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy…Rusch Intl.19974Class I
+1K955564Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileRusch, Inc.19965—
+2K122235Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc.20131—
+2K050166Portex Emergency Cricothyroidotomy KitSmiths Medical20050—
+2K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl.200312
+2K982128Shikani-French Speaking ValvePilling Weck Surgical19981—
+3K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc.20140—
+3K100995Shikani Speaking ValveShikani Medical, LLC20100—