FDA PMA

Normothermic preservation system for transplantation of initially unacceptable donor lungs

Номер PMA: P180014 · 2026-09-16

ЗаявительXvivo Perfusion, Inc.

Дата решения2026-09-16

Номер PMAP180014

Код продуктаPHO

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетGU

Описание устройства

Normothermic preservation system for transplantation of initially unacceptable donor lungs is the device name listed in this FDA 510(k) record. The listed applicant is Xvivo Perfusion, Inc.. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code PHO. It was reviewed by the GU advisory panel.

Часто задаваемые вопросы

What is the Normothermic preservation system for transplantation of initially unacceptable donor lungs?

Normothermic preservation system for transplantation of initially unacceptable donor lungs is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Xvivo Perfusion, Inc..

When did Normothermic preservation system for transplantation of initially unacceptable donor lungs receive FDA 510(k) clearance?

The clearance date for Normothermic preservation system for transplantation of initially unacceptable donor lungs can be found in the official FDA records.

Who is the listed applicant for Normothermic preservation system for transplantation of initially unacceptable donor lungs?

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

What is the FDA product code for Normothermic preservation system for transplantation of initially unacceptable donor lungs?

The FDA product code for Normothermic preservation system for transplantation of initially unacceptable donor lungs is PHO.

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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Официальный источник

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