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FDA 510(k)

CardioTag™

K-Number: K243566 · 2025-07-22

ApplicantCardiosense, Inc.
Decision Date2025-07-22
Product CodeDXR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioTag™ is the device name listed in this FDA 510(k) record. The listed applicant is Cardiosense, Inc.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243566. The device is classified under product code DXR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioTag™?

CardioTag™ is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Cardiosense, Inc.. The 510(k) number is K243566.

When did CardioTag™ receive FDA 510(k) clearance?

CardioTag™ received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243566.

Who is the listed applicant for CardioTag™?

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

What is the FDA product code for CardioTag™?

The FDA product code for CardioTag™ is DXR.

Related Devices (Code: DXR)

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.

K160656CorSensCorsens Medical , Ltd.

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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