FDA 510(k)

ATLAAS (無創傷左心耳附屬結構系統) (AD)

K 號：K252917 · 2026-05-22

決定日期2026-05-22

產品代碼PZX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Genesee Biomedical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：PZX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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