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FDA 510(k)

CPS Locator 3D Delivery Catheter

K-Number: K230363 · 2023-03-09

Decision Date2023-03-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPS Locator 3D Delivery Catheter is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2023-03-09 under approval number K230363. 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 Delivery Catheter?

CPS Locator 3D Delivery Catheter is a medical device that received FDA 510(k) clearance on 2023-03-09. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K230363.

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

CPS Locator 3D Delivery Catheter received FDA 510(k) clearance on 2023-03-09, under approval number K230363.

What company makes CPS Locator 3D Delivery Catheter?

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

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

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

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Official Source

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