510(k) Report

Devices descending from K181354

6 later devices reach 074 Zenith Flex System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190212AXS Vecta Aspiration SystemStryker Neurovascular20195—
+2K191768AXS Vecta Aspiration SystemStryker Neurovascular20194—
+3K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration…Maduro Medical, Inc.20260—
+3K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20252—
+4K253590Millipede SystemPerfuze, Ltd.20261—
+5K262399Millipede SystemPerfuze, Ltd.20260—