510(k) Report

Devices descending from K001346

3 later devices reach Ultimum Hemostasis Introducer, Model 4076XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093130Engage TR IntroducerSt Jude Medical200905
+1K092575Engage/Engage TRSt Jude Medical200905
+1K091137Ultimum/Engage/Engage TRSt Jude Medical200925