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FDA PMA

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation

Número do PMA: P200035 · 2026-08-07

RequerenteOrganox Limited
Data da decisão2026-08-07
Número PMAP200035
Código do produtoQQK
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoGU

Resumo do dispositivo

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is the device name listed in this FDA 510(k) record. The listed applicant is Organox Limited. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code QQK. It was reviewed by the GU advisory panel.

Perguntas frequentes

What is the Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Organox Limited.

When did Normothermic machine perfusion system for the preservation of donor livers prior to transplantation receive FDA 510(k) clearance?

The clearance date for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation can be found in the official FDA records.

Who is the listed applicant for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

The FDA 510(k) record lists Organox Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?

The FDA product code for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is QQK.

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Fonte oficial

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