510(k) Report

Devices descending from K043525

15 later devices reach Catheter Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171557AcQRef Introducer SheathAcutus Medical, Inc.20181—
+1K173287Elite HV RadialGalt Medical Corp.201702
+1K170695VenaCure EVLT NeverTouch Direct Introducer SheathAngioDynamics, Inc.20170—
+1K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp.20153—
+1K112398Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer with Side PortGalt Medical2012112
+2K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+2K182660GaltTWSGalt Medical Corp.20191—
+2K140028Galt Vti Low Insertion Valve Tearaway IntroducerGalt Medical Corp.20140—
+2K123430Microslider Tearaway Introducer SetGalt Medical Corp.20135—
+3K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)20220—
+3K153533Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp.201642
+4K261950Health Line Tearaway IntroducerHealth Line International Corporation20260—
+4K254236Peel-Away Introducer SheathVascuTech Medical, LLC20260—
+4K170020Peel-Away Introducer SetCook Incorporated20171—
+5K173685Peel-Away Introducer SetCook Incorporated20170—