510(k) Report

Devices descending from K091137

2 later devices reach Ultimum/Engage/Engage TR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093130Engage TR IntroducerSt Jude Medical200905
+1K092575Engage/Engage TRSt Jude Medical200905