510(k) Report

Devices descending from K990333

2 later devices reach Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200925Clarus Peel-Away Introducer SheathClarus Medical, LLC20210—
+1K061135Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019Aesculap20060—