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FDA 510(k)

Syntheon LAA 排除系統，Syntheon LAA 選擇指南

K 號：K220305 · 2022-10-28

申請人Syntheon
決定日期2022-10-28
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

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is the device name listed in this FDA 510(k) record. The listed applicant is Syntheon. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K220305. 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 Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Syntheon. The 510(k) number is K220305.

When did Syntheon LAA Exclusion System, Syntheon LAA Selection Guide receive FDA 510(k) clearance?

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide received FDA 510(k) clearance on 2022-10-28, under 510(k) number K220305.

Who is the listed applicant for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

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

What is the FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide?

The FDA product code for Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is PZX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K254232ECLIPTIS 左心房顯影囊排除系統 (ECS135)；ECLIPTIS 左心房顯影囊排除系統 (ECS140)；ECLIPTIS 左心房顯影囊排除系統 (ECS145)；ECLIPTIS 左心房顯影囊排除系統 (ECS150)Edwards LifesciencesK252917ATLAAS (無創傷左心耳附屬結構系統) (AD)Genesee Biomedical, Inc.K243860AtriClip PRO-Mini LAA 排除系統 (PROM)AtriCure, Inc.K234125AtriClip FLEX-Mini LAA 過濾系統 (ACHM)AtriCure, Inc.K233407AtriClip LAA 排除系統搭配預裝 Gillinov-Cosgrove 鈕 (LAA0)；AtriClip LAA 排除系統搭配預裝 Gillinov-Cosgrove 鈕 (ACH1)；AtriClip LAA 排除系統搭配預裝 Gillinov-Cosgrove 鈕 (ACH2)；AtriClip LAA 排除系統搭配預裝 Gillinov-Cosgrove 鈕 (PRO1)；AtriClip LAA 排除系統搭配預裝 Gillinov-Cosgrove 鈕 (PRO2)；AtriClip PRO-V LAA 排除系統 (PROV)；AtriClip Flex-V LAA 排除系統搭配預裝 V 鈕 (ACHV)AtriCure, Inc.K232295LAA排除系統Syntheon, LLC

官方來源

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