510(k) Report

Devices descending from K162804

4 later devices reach Q2 Low Pressure Power Injection Extension Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182897Velano Vascular Q2 Extension SetVelano Vascular20193—
+2K200439Velano ExT Extension SetVelano Vascular20212—
+3K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical20250—
+3K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical20220—