510(k) Report

Devices descending from K021096

6 later devices reach X-Sizer Catheter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+1K060016Thromcat Thrombectomy Catheter SystemKensey Nash Corp.200612
+2K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+2K072195Thromcat Thrombectomy Catheter SystemKensey Nash Corp.20070—
+3K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+4K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—