510(k) Report

Devices descending from K861310

2 later devices reach Stockert-Shiley Aortic Root Cannulae through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200612R501 aortic root cannula without vent line, R502 aortic root cannula with vent lineSorin Group Italia S.R.L.20201—
+2K240193R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26.…Sorin Group Italia S.R.L.20240—