510(k) Report

Devices descending from K103153

5 later devices reach Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Abbott Vascular20182—
+1K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited20161—
+2K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20260—
+2K220634NC TREK NEO Coronary Dilatation CatheterAbbott Vascular20220—
+2K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited20180—