510(k) Report

Devices descending from K914138

105 later devices reach Ontrac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+11K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+11K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+11K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+12K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—