510(k) Report

Devices descending from K191175

1 later device reach ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I