510(k) Report

Devices descending from K103110

9 later devices reach Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Abbott Vascular20182—
+1K112735Tamarin Blue Ptca RX Dilatation CatheterNatec Medical, Ltd.20125—
+2K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20260—
+2K220634NC TREK NEO Coronary Dilatation CatheterAbbott Vascular20220—
+2K210012Tamarin Blue PTCA RX Dilatation CatheterNatec Medical, Ltd.20210—
+2K141933Filao NC RX Ptca Dilatation CatheterNatec Medical, Ltd.20150—
+2K131169Mozec - RX Ptca Balloon Dilatation CatheterMeril Life Sciences Private Limited20132—
+3K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited20180—
+3K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited20161—