510(k) Report

Devices descending from K091352

1 later device reach Soundstar 3D Diagnostic Catheter, Model M-5723-05 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC20170—