510(k) Report

Devices descending from K122980

12 later devices reach Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142183Glidesheath SlenderTerumo Medical Corporation2014817
+1K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+2K181592RAIN Sheath TransradialCordis Corporation20180—
+2K181237Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation20182—
+2K181855RadialSeal Introducer KitGreat Batch Medical20180—
+2K173831Glidesheath SlenderTerumo Medical Corporation201811
+2K180081RAILWAY Sheathless Access SystemCordis Corporation20180—
+2K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+3K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp20230—
+3K220604EXTesia Introducer Sheath SetCuratia Medical Co.20220—
+3K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation20190—
+3K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—