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FDA 510(k)

FlexiGo 3D Delivery Catheter

K-Number: K250492 · 2025-06-18

ApplicantCenterPoint Systems, LLC
Decision Date2025-06-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexiGo 3D Delivery Catheter is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2025-06-18 under approval number K250492. 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 FlexiGo 3D Delivery Catheter?

FlexiGo 3D Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-06-18. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K250492.

When was FlexiGo 3D Delivery Catheter approved by the FDA?

FlexiGo 3D Delivery Catheter received FDA 510(k) clearance on 2025-06-18, under approval number K250492.

What company makes FlexiGo 3D Delivery Catheter?

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

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

The FDA product code for FlexiGo 3D Delivery Catheter is 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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