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CenterPoint Systems, LLC FDA Approvals

0 new drug approvals and 15 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
CPS Locator 3D Plus Delivery Catheter510(k)Jul 29, 2026Cardiovascular
SSPC NXT Delivery Catheter510(k)Jul 29, 2026Cardiovascular
FieldFlex Steerable Sheath510(k)Jun 5, 2026Cardiovascular
AuST Steerable Sheath510(k)Apr 7, 2026Cardiovascular
AuST CSP Introducer510(k)Feb 19, 2026Cardiovascular
CPS Locator 3D Plus Delivery Catheter510(k)Jun 27, 2025Cardiovascular
FlexiGo 3D Delivery Catheter510(k)Jun 18, 2025Cardiovascular
AuST Steerable Sheath510(k)Apr 30, 2025Cardiovascular
SSPC NXT Delivery Catheter510(k)Dec 4, 2024Cardiovascular
AuST Steerable Sheath510(k)Oct 4, 2024Cardiovascular
Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps510(k)May 2, 2024Gastroenterology, Urology
AuST Steerable Sheath510(k)May 1, 2024Cardiovascular
RenaNav Ureteroscope System510(k)Jul 31, 2023Gastroenterology, Urology
CPS Locator 3D Delivery Catheter510(k)Mar 9, 2023Cardiovascular
Guiding Catheter510(k)Nov 24, 2021Cardiovascular

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