FDA 510(k)

AtriClip FLEX-Mini LAA 排除系统 (ACHM)

K号: K234125 · 2024-07-29

决定日期2024-07-29

产品代码PZX

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决定实质等同

器械摘要

AtriClip FLEX-Mini LAA Exclusion System (ACHM) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2024-07-29 under 510(k) number K234125. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AtriClip FLEX-Mini LAA Exclusion System (ACHM)?

AtriClip FLEX-Mini LAA Exclusion System (ACHM) is a medical device that received FDA 510(k) clearance on 2024-07-29. The listed applicant is AtriCure, Inc.. The 510(k) number is K234125.

When did AtriClip FLEX-Mini LAA Exclusion System (ACHM) receive FDA 510(k) clearance?

AtriClip FLEX-Mini LAA Exclusion System (ACHM) received FDA 510(k) clearance on 2024-07-29, under 510(k) number K234125.

Who is the listed applicant for AtriClip FLEX-Mini LAA Exclusion System (ACHM)?

The FDA 510(k) record lists AtriCure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AtriClip FLEX-Mini LAA Exclusion System (ACHM)?

The FDA product code for AtriClip FLEX-Mini LAA Exclusion System (ACHM) is PZX.

列明AtriCure, 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。

K252056Isolator®Synergy®EnCompass夹具和引导系统（OLH，OSH，GPM100）K250371cryoICE cryoXT 冷冻消融探头（cryoXT）K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234151Isolator Synergy EnCapture消融系统（EMH）K233959EPi-Ease epicardial access device (EAS)

查看所有 32 个设备 →

相关器械（代码：PZX）

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。

K254232ECLIPTIS 左心耳附壁排除系统 (ECS135)；ECLIPTIS 左心耳附壁排除系统 (ECS140)；ECLIPTIS 左心耳附壁排除系统 (ECS145)；ECLIPTIS 左心耳附壁排除系统 (ECS150)Edwards Lifesciences K252917ATLAAS (无创左心耳附加装置) (AD)Genesee Biomedical, Inc.K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)AtriCure, Inc.K232295LAA 排除系统Syntheon, LLC K220305Syntheon LAA排除系统，Syntheon LAA选择指南Syntheon

官方来源

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