510(k) Report

Devices descending from K191559

1 later device reach AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle TubingDiversatek Healthcare20220—