用于移植最初不可接受的捐赠者肺的常温保存系统
PMA编号：P180014 · 2026-09-16
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决定日期2026-09-16
PMA 编号P180014
产品代码PHO
设备分类第3类
医疗专科U
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
器械摘要
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.
常见问题
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.
Normothermic preservation system for transplantation of initially unacceptable donor lungs的申请人名单是谁？
The FDA 510(k) record lists Xvivo Perfusion, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是用于移植最初不可接受的捐赠肺的常温保存系统的FDA产品代码？
FDA产品代码为用于移植最初不可接受的捐赠肺的常温保存系统的产品代码是PHO。
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官方来源
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