510(k) Report

Devices descending from K000313

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.201642
+1K123430Microslider Tearaway Introducer SetGalt Medical Corp.20135—
+1K122854Arrow Glidethru Peel-Away Sheath/Dilator IntroducerArrow International (Subsidiary of Teleflex Inc.)201302
+1K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+1K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortGalt Medical2012112
+1K043525Catheter IntroducerGalt Medical Corp.2005153
+2K261950Health Line Tearaway IntroducerHealth Line International Corporation20260—
+2K254236Peel-Away Introducer SheathVascuTech Medical, LLC20260—
+2K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+2K173287Elite HV RadialGalt Medical Corp.201702
+2K170020Peel-Away Introducer SetCook Incorporated20171—
+2K170695VenaCure EVLT NeverTouch Direct Introducer SheathAngioDynamics, Inc.20170—
+2K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp.20153—
+2K140028Galt Vti Low Insertion Valve Tearaway IntroducerGalt Medical Corp.20140—
+2K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+3K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+3K182660GaltTWSGalt Medical Corp.20191—
+3K173685Peel-Away Introducer SetCook Incorporated20170—
+3K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—
+4K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)20220—