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FDA 510(k)

RayFlow

K-Number: K222023 · 2023-04-06

ApplicantHexacath
Decision Date2023-04-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RayFlow is a medical device manufactured by Hexacath. It received FDA 510(k) clearance on 2023-04-06 under approval number K222023. 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 RayFlow?

RayFlow is a medical device that received FDA 510(k) clearance on 2023-04-06. It is manufactured by Hexacath. The 510(k) number is K222023.

When was RayFlow approved by the FDA?

RayFlow received FDA 510(k) clearance on 2023-04-06, under approval number K222023.

What company makes RayFlow?

RayFlow is manufactured by Hexacath.

What is the FDA product code for RayFlow?

The FDA product code for RayFlow is DQY.

Related Devices (Code: DQY)

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.