510(k) Report

Devices descending from K133237

2 later devices reach Gel-Bead Embolization Spheres through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…Vascular Solutions, Inc.20180—
+1K171946Gel-BeadVascular Solutions, Inc.20171—