510(k) Report

Devices descending from K181814

1 later device reach AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200556AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc.20200—