510(k) Report

Devices descending from K083301

3 later devices reach X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132811Sarns Soft-Flow Extended Aortic CannulaTerumo Cardiovascular Systems Corporation20140—
+1K132451Sarns Soft-Flow Aortic CannulaTerumo Cardiovascular Systems Corp.20140—
+1K133151Sarns High Flow Aortic Arch CannulaTerumo Cardiovascular Systems Corp.20140—