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FDA PMA

Normothermic preservation system for transplantation of initially unacceptable donor lungs

Número do PMA: P180014 · 2026-09-16

RequerenteXvivo Perfusion, Inc.
Data da decisão2026-09-16
Número PMAP180014
Código do produtoPHO
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoGU

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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