FDA 510(k)

angioLOCK 聚合物結合夾

K 號：K220006 · 2022-03-02

決定日期2022-03-02

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

angioLOCK Polymer Ligating Clip is the device name listed in this FDA 510(k) record. The listed applicant is A2 Medical Systems, LLC. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K220006. 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 angioLOCK Polymer Ligating Clip?

angioLOCK Polymer Ligating Clip is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is A2 Medical Systems, LLC. The 510(k) number is K220006.

When did angioLOCK Polymer Ligating Clip receive FDA 510(k) clearance?

angioLOCK Polymer Ligating Clip received FDA 510(k) clearance on 2022-03-02, under 510(k) number K220006.

Who is the listed applicant for angioLOCK Polymer Ligating Clip?

The FDA 510(k) record lists A2 Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for angioLOCK Polymer Ligating Clip?

The FDA product code for angioLOCK Polymer Ligating Clip is FZP.

其他以 A2 Medical Systems, LLC 為申請人之記錄

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K230966angiOCCLUDE 結合夾

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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