510(k) Report

Devices descending from K173063

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+2K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I