Medical Device Manufacturer · US , West Valley City , UT

CenterPoint Systems, LLC - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2021

Official Website

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - CenterPoint Systems, LLC Cardiovascular ✕

10 devices

1-10 of 10

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 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