CenterPoint Systems, LLC - FDA 510(k) Cleared Devices
11
Total
11
Cleared
0
Denied
FDA 510(k) cleared devices by CenterPoint Systems, LLC Cardiovascular ✕
9 devices
Cleared
Feb 19, 2026
AuST CSP Introducer
Cardiovascular
30d
Cleared
Jun 27, 2025
CPS Locator 3D Plus Delivery Catheter
Cardiovascular
100d
Cleared
Jun 18, 2025
FlexiGo 3D Delivery Catheter
Cardiovascular
118d
Cleared
Apr 30, 2025
AuST Steerable Sheath
Cardiovascular
27d
Cleared
Dec 04, 2024
SSPC NXT Delivery Catheter
Cardiovascular
65d
Cleared
Oct 04, 2024
AuST Steerable Sheath
Cardiovascular
78d
Cleared
May 01, 2024
AuST Steerable Sheath
Cardiovascular
36d
Cleared
Mar 09, 2023
CPS Locator 3D Delivery Catheter
Cardiovascular
27d
Cleared
Nov 24, 2021
Guiding Catheter
Cardiovascular
324d