510(k) Report

Devices descending from K161640

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+1K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+1K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.202101
+1K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.202121
+1K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker20190—
+1K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.201810—
+2K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.20260—
+2K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.20221—
+2K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20213—
+2K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.20193Class I
+2K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+3K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+3K251006NeVasc Aspiration SystemVesalio, Inc.20250—
+3K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.20251—
+3K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+3K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+4K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I