CardioTag
K-Number: K243566 · 2025-07-22
ApplicantCardiosense, Inc.
Decision Date2025-07-22
Product CodeDXR
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CardioTag is a medical device manufactured by Cardiosense, Inc.. It received FDA 510(k) clearance on 2025-07-22 under approval 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. It is manufactured by Cardiosense, Inc.. The 510(k) number is K243566.
When was CardioTag approved by the FDA?
CardioTag received FDA 510(k) clearance on 2025-07-22, under approval number K243566.
What company makes CardioTag?
CardioTag is manufactured by Cardiosense, Inc..
What is the FDA product code for CardioTag?
The FDA product code for CardioTag is DXR.
Related Devices (Code: DXR)
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.