510(k) Report

Devices descending from K111295

9 later devices reach .014 Monorail and Otw Pta Balloon Dilatation Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+1K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC20151—
+1K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+1K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME20143—
+2K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+2K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC202301
+2K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+2K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+2K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—