FDA 510(k)

AtriClip LAA 排除系統搭配預裝 Gillinov-Cosgrove 鈕

K 號：K160454 · 2016-03-18

決定日期2016-03-18

產品代碼FZP

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

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K160454. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is AtriCure, Inc.. The 510(k) number is K160454.

When did AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip receive FDA 510(k) clearance?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip received FDA 510(k) clearance on 2016-03-18, under 510(k) number K160454.

Who is the listed applicant for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip?

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 LAA Exclusion System with preloaded Gillinov-Cosgrove Clip?

The FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is FZP.

其他以 AtriCure, Inc. 為申請人之記錄

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相關器械（代碼：FZP）

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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