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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 the device name listed in this FDA 510(k) record. The listed applicant is Helios Cardio, Inc.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) 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. The listed applicant is Helios Cardio, Inc.. The 510(k) number is K210331.

When did CardiaMend Pericardial and Epicardial Reconstruction Matrix receive FDA 510(k) clearance?

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

Who is the listed applicant for CardiaMend Pericardial and Epicardial Reconstruction Matrix?

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

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.

Related Devices (Code: PSQ)

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.

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.K200566ADAPT TissueAdmedus Regen Pty, Ltd.K190882XenoSure Biologic PatchLemaitre VascularK191734MatriStem UBM Pericardial PatchAcell, Inc.K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

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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