二尖瓣修复设备
PMA编号：P220003 · 2026-09-23
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器械摘要
Mitral valve repair devices is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-09-23. The device is classified under product code NKM. It was reviewed by the CV advisory panel.
常见问题
What is the Mitral valve repair devices?
Mitral valve repair devices is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Edwards Lifesciences, LLC.
When did Mitral valve repair devices receive FDA 510(k) clearance?
The clearance date for Mitral valve repair devices can be found in the official FDA records.
Who is the listed applicant for Mitral valve repair devices?
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mitral valve repair devices?
The FDA product code for Mitral valve repair devices is NKM.
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官方来源
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