510(k) Report

Devices descending from K122609

3 later devices reach Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181651Radial Medical Compression SystemRadial Medical, Inc.20181—
+1K131046Vasculaire Compression System, Vasculaire Sleeve (Foot & Calf), Vasculaire Sleeve (Calf)Venous Health Systems, Inc.20130—
+2K190976Radial Medical Compression SystemRadial Medical, Inc.20190—