510(k) Report

Devices descending from K170997

3 later devices reach CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathBaylis Medical Company, Inc.20230—
+1K231412CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)Biosense Webster, Inc.20230—
+1K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC20220—