510(k) Report

Devices descending from K191946

2 later devices reach Penumbra System Penumbra JET 7X through their predicates, nearest generation first.

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