510(k) Report

Devices descending from K190010

3 later devices reach Penumbra System Reperfusion Catheter JET 7 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…Penumbra, Inc.20200Class I
+1K191946Penumbra System Penumbra JET 7XPenumbra, Inc.20202Class I
+2K222786072 Aspiration SystemQ'Apel Medical, Inc.20230Class I