510(k) Report

Devices descending from K891022

12 later devices reach Introducer for Ptca Guiding Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963388Vessel DilatorMaxxim Medical199711—
+2K093554Retroflex Dilator KitEdwards Lifesciences, LLC20102—
+2K070749Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting200710—
+3K123842Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd.20131—
+3K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech20091—
+3K081940Avalon Elite Vascular Access KitAvalon Laboratories, LLC200841
+4K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)Sorin Group Italia S.R.L.20250—
+4K182914MC3 Vascular Access Kit 21030Mc3 Incorporated20180—
+4K170616van Andel Dilatation CatheterCook Incorporated20170—
+4K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc.201711
+4K120349Sonixgps Vascular Access Needle KitUltrasonix Medical Corpation20120—
+5K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.20250—