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FDA 510(k)

The Heart Seat

K-Number: K222330 · 2023-04-24

ApplicantCasana Care, Inc.
Decision Date2023-04-24
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The Heart Seat is a medical device manufactured by Casana Care, Inc.. It received FDA 510(k) clearance on 2023-04-24 under approval number K222330. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Heart Seat?

The Heart Seat is a medical device that received FDA 510(k) clearance on 2023-04-24. It is manufactured by Casana Care, Inc.. The 510(k) number is K222330.

When was The Heart Seat approved by the FDA?

The Heart Seat received FDA 510(k) clearance on 2023-04-24, under approval number K222330.

What company makes The Heart Seat?

The Heart Seat is manufactured by Casana Care, Inc..

What is the FDA product code for The Heart Seat?

The FDA product code for The Heart Seat is MWI.

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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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