510(k) Report

Devices descending from K991170

1 later device reach Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123187Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter…Edwards Lifesciences, LLC20130—