FDA 510(k)

CardiaMend Pericardial and Epicardial Reconstruction Matrix

N.º K: K210331 · 2021-12-21

Fecha de decisión2021-12-21

Código de productoPSQ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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