510(k) Report

Devices descending from K192344

3 later devices reach Sapphire NC Plus Coronary Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211807Sapphire NC 24OrbusNeich Medical (Shenzhen) Co., Ltd.20211—
+1K202578KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd.20210—
+2K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—