510(k) Report

Devices descending from K191313

3 later devices reach Unity Subcutaneous Infusion System for Remodulin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243354Remunity SystemDeka Research & Development Corp.20240—
+1K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development20201—
+2K240256Remunity SystemDeka Research and Development20240—