510(k) Report

Devices descending from K181237

2 later devices reach Glidesheath Slender Tibial Pedal Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230704RAIN Sheath™ Tibial Pedal IntroducerCordis US Corp20230—
+1K193160Glidesheath Slender Tibial Pedal KitTerumo Medical Coporation20190—