510(k) Report

Devices descending from K080500

9 later devices reach Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101885Medtronic C315 Delivery CatheterMedtronic, Inc.201081
+2K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left…Medtronic, Inc.20201—
+2K190475Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery…Centerpoint Systems20195—
+3K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC20250—
+3K230363CPS Locator 3D Delivery CatheterCenterPoint Systems, LLC20233—
+3K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemMedtronic20220—
+4K250147CPS Locator 3D Delivery CatheterCenterpoint Systems20250—
+4K250828CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20251—
+5K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—