510(k) Report

Devices descending from K153440

2 later devices reach PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.20171—
+2K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.20240—