用于移植前保存标准标准捐赠肺的Normothermic机器灌注系统
PMA编号：P160013 · 2026-05-13
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器械摘要
常见问题
What is the Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?
Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is TransMedics, Inc..
When did Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation receive FDA 510(k) clearance?
The clearance date for Normothermic machine perfusion system for the preservation of standard criteria donor lungs 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 standard criteria donor lungs prior to transplantation?
The FDA 510(k) record lists TransMedics, Inc. 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 standard criteria donor lungs prior to transplantation?
The FDA product code for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is QBA.
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官方来源
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