510(k) Report

Devices descending from K153102

3 later devices reach QuadraSphere Microspheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172372QuadraSphere MicrospheresBiosphere Medical, S.A.20172—
+2K231554UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.20231—
+3K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.20260—