510(k) Report

Devices descending from K110617

5 later devices reach Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Abbott Vascular20182—
+1K173680Sapphire II PROOrbusneich Medical Trading, Inc.20181—
+2K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20260—
+2K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+2K220634NC TREK NEO Coronary Dilatation CatheterAbbott Vascular20220—