510(k) Report

Devices descending from K113769

4 later devices reach Gpscath Ballon Dilatation Catheter through their predicates, nearest generation first.

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