510(k) Report

Devices descending from K162901

16 later devices reach Penumbra 3D Revascularization Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.202101
+1K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.202121
+1K190464Penumbra System 3D Revascularization DevicePenumbra, Inc.20190—
+1K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+1K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc.201810—
+1K180008Penumbra SystemPenumbra, Inc.20180—
+2K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+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
+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