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FDA 510(k)

CPS Locator 3D Plus Delivery Catheter

K-Number: K250828 · 2025-06-27

ApplicantCenterPoint Systems, LLC
Decision Date2025-06-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPS Locator 3D Plus Delivery Catheter is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2025-06-27 under approval number K250828. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPS Locator 3D Plus Delivery Catheter?

CPS Locator 3D Plus Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K250828.

When was CPS Locator 3D Plus Delivery Catheter approved by the FDA?

CPS Locator 3D Plus Delivery Catheter received FDA 510(k) clearance on 2025-06-27, under approval number K250828.

What company makes CPS Locator 3D Plus Delivery Catheter?

CPS Locator 3D Plus Delivery Catheter is manufactured by CenterPoint Systems, LLC.

What is the FDA product code for CPS Locator 3D Plus Delivery Catheter?

The FDA product code for CPS Locator 3D Plus Delivery Catheter is DQY.

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Other Devices by CenterPoint Systems, LLC

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Related Devices (Code: DQY)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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