510(k) Report

Devices descending from K180864

2 later devices reach WATCHMAN TruSeal Access System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+2K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I