DuraGraft血管导管解决方案
K号: K240925 · 2024-05-01
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申请人Marizyme
决定日期2024-05-01
产品代码QEJ
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。
决定实质等同
器械摘要
DuraGraft Vascular Conduit Solution is the device name listed in this FDA 510(k) record. The listed applicant is Marizyme. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K240925. The device is classified under product code QEJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DuraGraft Vascular Conduit Solution?
DuraGraft Vascular Conduit Solution is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Marizyme. The 510(k) number is K240925.
When did DuraGraft Vascular Conduit Solution receive FDA 510(k) clearance?
DuraGraft Vascular Conduit Solution received FDA 510(k) clearance on 2024-05-01, under 510(k) number K240925.
Who is the listed applicant for DuraGraft Vascular Conduit Solution?
The FDA 510(k) record lists Marizyme as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DuraGraft Vascular Conduit Solution?
The FDA product code for DuraGraft Vascular Conduit Solution is QEJ.
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官方来源
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