510(k) Report

Devices descending from K110450

2 later devices reach Agilis NXT Steerable Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210185CardioCurve Steerable SheathTalon Surgical20211—
+2K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…Circa Scientific, Inc.20240—