510(k) Report

Devices descending from K140351

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+1K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+1K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—