FDA 510(k)

CardiaMend Pericardial and Epicardial Reconstruction Matrix

Номер K: K210331 · 2021-12-21

Дата решения2021-12-21

Код продуктаPSQ

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: PSQ)

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.K200566ADAPT ТканьAdmedus Regen Pty, Ltd.K190882XenoSure Biologic PatchLemaitre Vascular K191734MatriStem UBM Pericardial PatchAcell, Inc.K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

Официальный источник

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