LotusCatheter（Lotus无球囊导管）
K号: K191512 · 2020-05-21
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决定日期2020-05-21
产品代码GBM
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Unknown
器械摘要
LotusCatheter (Lotus No Balloon Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Hakki Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K191512. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.
常见问题
What is the LotusCatheter (Lotus No Balloon Catheter)?
LotusCatheter (Lotus No Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Hakki Medical Technologies, Inc.. The 510(k) number is K191512.
When did LotusCatheter (Lotus No Balloon Catheter) receive FDA 510(k) clearance?
LotusCatheter (Lotus No Balloon Catheter) received FDA 510(k) clearance on 2020-05-21, under 510(k) number K191512.
Who is the listed applicant for LotusCatheter (Lotus No Balloon Catheter)?
The FDA 510(k) record lists Hakki Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LotusCatheter (Lotus No Balloon Catheter)?
The FDA product code for LotusCatheter (Lotus No Balloon Catheter) is GBM.
相关临床试验
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相关器械（代码：GBM）
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。
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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