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FDA 510(k)

iTFlow

K-Number: K222854 · 2023-05-12

ApplicantCardio Flow Design, Inc.
Decision Date2023-05-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iTFlow is a medical device manufactured by Cardio Flow Design, Inc.. It received FDA 510(k) clearance on 2023-05-12 under approval number K222854. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTFlow?

iTFlow is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Cardio Flow Design, Inc.. The 510(k) number is K222854.

When was iTFlow approved by the FDA?

iTFlow received FDA 510(k) clearance on 2023-05-12, under approval number K222854.

What company makes iTFlow?

iTFlow is manufactured by Cardio Flow Design, Inc..

What is the FDA product code for iTFlow?

The FDA product code for iTFlow is LLZ.

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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.

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