510(k) Report

Devices descending from K003424

5 later devices reach Pinnacle R/O II or Radifocus Introducer II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082847Pinnacle Roii Introducer SheathTerumo Medical Corp.20083—
+1K062446Modification to Pinnacle Roii Hiflow Introducer SheathTerumo Medical Corp.20060—
+2K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+3K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+4K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—