510(k) Report

Devices descending from K101047

5 later devices reach Pta-Duo Pta Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113769Gpscath Ballon Dilatation CatheterHotspur Technologies20124—
+2K130397Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies20133—
+3K151678Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.20152—
+4K163231Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.201712
+5K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.20170—