510(k) Report

Devices descending from K030813

3 later devices reach Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202698Prefilled SyringeHangzhou Primecare Medical Co., Ltd.20200—
+1K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc.20181—
+2K200556AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc.20200—