FDA 510(k)

ATLAAS (无创左心耳附加装置) (AD)

K号: K252917 · 2026-05-22

决定日期2026-05-22

产品代码PZX

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决定实质等同

器械摘要

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is the device name listed in this FDA 510(k) record. The listed applicant is Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K252917. 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 ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K252917.

When did ATLAAS (Atraumatic Left Atrial Appendage System) (AD) receive FDA 510(k) clearance?

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) received FDA 510(k) clearance on 2026-05-22, under 510(k) number K252917.

Who is the listed applicant for ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

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

What is the FDA product code for ATLAAS (Atraumatic Left Atrial Appendage System) (AD)?

The FDA product code for ATLAAS (Atraumatic Left Atrial Appendage System) (AD) is PZX.

列明Genesee Biomedical, 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。

K250859Transform McCarthy 二尖瓣成形环（TF）K232599Transform McCarthy 二尖瓣成形环（TF）K230679WellsForm 三尖瓣环成形带（WF）K202253TruForm Sievers 心脏瓣膜成形环 K190506NeoForm 环形瓣膜 K161815FlexForm 环形瓣膜和 FlexForm 环形瓣膜带

查看所有 7 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 K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.K234125AtriClip FLEX-Mini LAA 排除系统 (ACHM)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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