510(k) Report

Devices descending from K121667

8 later devices reach NC Quantum Apex Ptca Dilatation Catheter (Monorail) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162434NC Gallant PTCA CatheterMedinol, Ltd.20171—
+1K160823NC Quantum Apex PTCA Dilatation CatheterBoston Scientific Corporation20160—
+1K143160FOXTROT NC PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20150—
+1K141236NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter…Boston Scientific Corporation201431
+2K223189Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.20230—
+2K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.20220—
+2K211393Selethru (TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20210—
+2K173581Gallant PTCA Dilatation CatheterMedinol, Ltd.20180—