510(k) Report

Devices descending from K190475

5 later devices reach Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+1K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+2K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+2K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+3K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—