510(k) Report

Devices descending from K914088

3 later devices reach Bivona Aire-Cuf (R) Pediatric Tracheostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972546Rusch Single Use Crystal Tracheostomy Tube SetRusch Intl.19982—
+2K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl.200312
+3K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc.20140—