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CardiaMend Pericardial and Epicardial Reconstruction Matrix

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210331

by Helios Cardio, Inc.

Identifiers

510(k) Number
K210331 FDA 510(k)
FDA Product Code
PSQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3470 FDA 510(k)
Regulation Number
870.3470 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CardiaMend is a porous, acellular, single-layer matrix derived from fetal bovine dermis, consisting of naturally woven collagen fibers. It is indicated for pericardial repair and reconstruction and for epicardial support and repair. The device combines mechanical properties and biocompatibility required for these cardiac applications.

CardiaMend is supplied as a single-layer matrix used for soft tissue reinforcement, repair, and reconstruction. It is a Class II device cleared by the FDA under product code PSQ for cardiovascular use. The device is based on f-EBM technology and is intended for single use in pericardial and epicardial procedures.

Frequently asked questions

What is CardiaMend used for?

CardiaMend is indicated for pericardial repair and reconstruction, as well as for epicardial support and repair. It is designed to provide mechanical properties and biocompatibility required for cardiac applications.

How is CardiaMend supplied?

CardiaMend is supplied as a single-layer matrix used for soft tissue reinforcement, repair, and reconstruction. It is based on f-EBM technology and is intended for single use in pericardial and epicardial procedures.

Is CardiaMend sterile?

The device information does not specify sterility status. For specific details on sterility, please consult the product documentation or contact the manufacturer directly.

What is the regulatory status of CardiaMend?

CardiaMend is a Class II device cleared by the FDA under product code PSQ for cardiovascular use. It received FDA clearance through the traditional 510(k) process with decision code SESE.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CardiaMend — Helios Cardio, Helios Cardio, CardiaMend Pericardial and Epicardial Reconstruction Matrix

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helios Cardio, Inc.

Sources (1)

  • FDA 510(k) K210331 24 fields · synced Sep 26, 2026