吸痰导管（2189）
K号: K241874 · 2024-09-24
广告
决定日期2024-09-24
产品代码OCX
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
Aspiration Catheter (2189) is the device name listed in this FDA 510(k) record. The listed applicant is Hobbs Medical, Inc.. It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K241874. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aspiration Catheter (2189)?
Aspiration Catheter (2189) is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Hobbs Medical, Inc.. The 510(k) number is K241874.
When did Aspiration Catheter (2189) receive FDA 510(k) clearance?
Aspiration Catheter (2189) received FDA 510(k) clearance on 2024-09-24, under 510(k) number K241874.
Who is the listed applicant for Aspiration Catheter (2189)?
The FDA 510(k) record lists Hobbs Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aspiration Catheter (2189)?
The FDA product code for Aspiration Catheter (2189) is OCX.
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。
列明Hobbs Medical, Inc.为申报人的其他记录
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：OCX）
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。
K251986辅助水管 MAJ-855Olympus Medical Systems CorporationK251997单次使用活检阀（MAJ-1555）Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704内镜水泵Hangzhou AGS MedTech Co., Ltd.K242357水容器（MAJ-901）；水容器（MAJ-902）Olympus Medical Systems CorporationK242134ClearCap远端附件Finemedix Co., Ltd.
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。
广告