510(k) Report

Devices descending from K935170

110 later devices reach Cardiovascular and Vascular Guidewire Modifications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+9K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+9K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+9K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+10K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+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—