RayFlow
K-Number: K222023 · 2023-04-06
ApplicantHexacath
Decision Date2023-04-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RayFlow is the device name listed in this FDA 510(k) record. The listed applicant is Hexacath. It received FDA 510(k) clearance on 2023-04-06 under 510(k) 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. The listed applicant is Hexacath. The 510(k) number is K222023.
When did RayFlow receive FDA 510(k) clearance?
RayFlow received FDA 510(k) clearance on 2023-04-06, under 510(k) number K222023.
Who is the listed applicant for RayFlow?
The FDA 510(k) record lists Hexacath as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RayFlow?
The FDA product code for RayFlow 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.