510(k) Report

Devices descending from K083402

1 later device reach Agilis NXT Steerable Introducer, Model G408322 and G408323 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical201003