FLUME 导管
K号: K212151 · 2021-11-03
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决定日期2021-11-03
产品代码EZL
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
FLUME catheter is the device name listed in this FDA 510(k) record. The listed applicant is The Flume Catheter Company, Ltd.. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K212151. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FLUME catheter?
FLUME catheter is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is The Flume Catheter Company, Ltd.. The 510(k) number is K212151.
When did FLUME catheter receive FDA 510(k) clearance?
FLUME catheter received FDA 510(k) clearance on 2021-11-03, under 510(k) number K212151.
Who is the listed applicant for FLUME catheter?
The FDA 510(k) record lists The Flume Catheter Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FLUME catheter?
The FDA product code for FLUME catheter is EZL.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：EZL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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