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FDA 510(k)

CardiaMend Pericardial and Epicardial Reconstruction Matrix

K-Number: K210331 · 2021-12-21

ApplicantHelios Cardio, Inc.
Decision Date2021-12-21
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardiaMend Pericardial and Epicardial Reconstruction Matrix is a medical device manufactured by Helios Cardio, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K210331. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardiaMend Pericardial and Epicardial Reconstruction Matrix?

CardiaMend Pericardial and Epicardial Reconstruction Matrix is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Helios Cardio, Inc.. The 510(k) number is K210331.

When was CardiaMend Pericardial and Epicardial Reconstruction Matrix approved by the FDA?

CardiaMend Pericardial and Epicardial Reconstruction Matrix received FDA 510(k) clearance on 2021-12-21, under approval number K210331.

What company makes CardiaMend Pericardial and Epicardial Reconstruction Matrix?

CardiaMend Pericardial and Epicardial Reconstruction Matrix is manufactured by Helios Cardio, Inc..

What is the FDA product code for CardiaMend Pericardial and Epicardial Reconstruction Matrix?

The FDA product code for CardiaMend Pericardial and Epicardial Reconstruction Matrix is PSQ.

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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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