510(k) Report

Devices descending from K162925

2 later devices reach AcQGuide Steerable Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc.20211—
+2K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.20220—