510(k) Report

Devices descending from K082847

3 later devices reach Pinnacle Roii Introducer Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132592Flexor Radial Hydrophilic Introducer Access SetCook, Inc.201427
+2K152044Flexor Radial Hydrophilic Introducer Access SetCook Incorporated20151—
+3K171609Check-Flo Performer Introducer Micropuncture Radial Artery Access SetCook Incorporated20180—