510(k) Report

Devices descending from K964056

4 later devices reach Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122235Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc.20131—
+1K982128Shikani-French Speaking ValvePilling Weck Surgical19981—
+2K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc.20140—
+2K100995Shikani Speaking ValveShikani Medical, LLC20100—