CenterPoint Systems, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
CenterPoint Systems, LLC - FDA 510(k) Cleared Devices
Recent clearances: FieldFlex Steerable Sheath, AuST Steerable Sheath, AuST CSP Introducer
15
Total
15
Cleared
0
Denied
CenterPoint Systems, LLC has 15 FDA 510(k) cleared cardiovascular devices. Based in West Valley City, US.
Latest FDA clearance: Jul 2026. Active since 2021.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - CenterPoint Systems, LLC
15 devices
Cleared
Jul 29, 2026
CPS Locator 3D Plus Delivery Catheter
Cardiovascular
62d
Cleared
Jul 29, 2026
SSPC NXT Delivery Catheter
Cardiovascular
28d
Cleared
Jun 05, 2026
FieldFlex Steerable Sheath
Cardiovascular
30d
Cleared
Apr 07, 2026
AuST Steerable Sheath
Cardiovascular
18d
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 02, 2024
Dragonfly™ Pancreaticobiliary Scope
Gastroenterology & Urology
162d
Cleared
May 01, 2024
AuST Steerable Sheath
Cardiovascular
36d
Cleared
Jul 31, 2023
RenaNav Ureteroscope System
Gastroenterology & Urology
304d
Cleared
Mar 09, 2023
CPS Locator 3D Delivery Catheter
Cardiovascular
27d
Cleared
Nov 24, 2021
Guiding Catheter
Cardiovascular
324d