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

Cleared Jun 05, 2026

FieldFlex Steerable Sheath

K261492 · DYB

Cardiovascular · 30d

Cleared Apr 07, 2026

AuST Steerable Sheath

K260942 · DYB

Cardiovascular · 18d

Cleared Feb 19, 2026

AuST CSP Introducer

K260163 · DYB

Cardiovascular · 30d

Cleared Jun 27, 2025

CPS Locator 3D Plus Delivery Catheter

K250828 · DQY

Cardiovascular · 100d

Cleared Jun 18, 2025

FlexiGo 3D Delivery Catheter

K250492 · DQY

Cardiovascular · 118d

Cleared Apr 30, 2025

AuST Steerable Sheath

K251051 · DYB

Cardiovascular · 27d

Cleared Dec 04, 2024

SSPC NXT Delivery Catheter

K243180 · DQY

Cardiovascular · 65d

Cleared Oct 04, 2024

AuST Steerable Sheath

K242106 · DYB

Cardiovascular · 78d

Cleared May 01, 2024

AuST Steerable Sheath

K240829 · DYB

Cardiovascular · 36d

Cleared Mar 09, 2023

CPS Locator 3D Delivery Catheter

K230363 · DQY

Cardiovascular · 27d

Cleared Nov 24, 2021

Guiding Catheter

K210009 · DQY

Cardiovascular · 324d