angiOCCLUDE 结扎夹
K号: K230966 · 2023-09-19
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决定日期2023-09-19
产品代码FZP
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
angiOCCLUDE Ligating Clips is the device name listed in this FDA 510(k) record. The listed applicant is A2 Medical Systems, LLC. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K230966. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the angiOCCLUDE Ligating Clips?
angiOCCLUDE Ligating Clips is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is A2 Medical Systems, LLC. The 510(k) number is K230966.
When did angiOCCLUDE Ligating Clips receive FDA 510(k) clearance?
angiOCCLUDE Ligating Clips received FDA 510(k) clearance on 2023-09-19, under 510(k) number K230966.
Who is the listed applicant for angiOCCLUDE Ligating Clips?
The FDA 510(k) record lists A2 Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for angiOCCLUDE Ligating Clips?
The FDA product code for angiOCCLUDE Ligating Clips is FZP.
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A2 Medical Systems, LLC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：FZP）
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。
K260677血管闭合装置（VCD177213P）Vcd Medical S.R.L.K254231Inno-Hook™ 一次性夹子应用器（结扎夹）和 Inno-Hook™ 结扎夹Taiwan Surgical CorporationK253781InnoClip 套管夹应用器Taiwan Surgical CorporationK253903InnoClip 一次性套管夹应用器Taiwan Surgical CorporationK250643一次性聚合物结扎夹Hangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical
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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