510(k) Report

Devices descending from K130397

3 later devices reach Arrow Gpscath Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151678Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.20152—
+2K163231Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.201712
+3K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.20170—