510(k) Report

Devices descending from K153533

4 later devices reach Tearaway Introducer Sheath, MicroSlide Tearaway Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261950Health Line Tearaway IntroducerHealth Line International Corporation20260—
+1K254236Peel-Away Introducer SheathVascuTech Medical, LLC20260—
+1K170020Peel-Away Introducer SetCook Incorporated20171—
+2K173685Peel-Away Introducer SetCook Incorporated20170—