FDA 510(k)

iTFlow

K-Number: K222854 · 2023-05-12

Decision Date2023-05-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

iTFlow is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Flow Design, Inc.. It received FDA 510(k) clearance on 2023-05-12 under 510(k) 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. The listed applicant is Cardio Flow Design, Inc.. The 510(k) number is K222854.

When did iTFlow receive FDA 510(k) clearance?

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

Who is the listed applicant for iTFlow?

The FDA 510(k) record lists Cardio Flow Design, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTFlow?

The FDA product code for iTFlow is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.