510(k) Report

Devices descending from K161064

15 later devices reach Penumbra System ACE 68 Reperfusion Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20230Class I
+1K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+1K182101Riptide Aspiration System (React 71 Catheter)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+1K180705Riptide Aspiration System React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20181—
+1K172167Zenith Flex SystemInneuroco, Inc.201871
+2K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+2K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+2K181354074 Zenith Flex SystemInneuroco, Inc.201861
+3K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+3K190212AXS Vecta Aspiration SystemStryker Neurovascular20195—
+4K191768AXS Vecta Aspiration SystemStryker Neurovascular20194—
+5K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration…Maduro Medical, Inc.20260—
+5K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20252—
+6K253590Millipede SystemPerfuze, Ltd.20261—
+7K262399Millipede SystemPerfuze, Ltd.20260—