510(k) Report

Devices descending from K151678

2 later devices reach Chameleon PTA Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163231Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.201712
+2K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.20170—