FDA 510(k)

SafeBreak® 頸動脈血管

K 號：K223486 · 2023-05-19

決定日期2023-05-19

產品代碼QOI

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

SafeBreak® Vascular is the device name listed in this FDA 510(k) record. The listed applicant is Lineus Medical. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K223486. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SafeBreak® Vascular?

SafeBreak® Vascular is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Lineus Medical. The 510(k) number is K223486.

When did SafeBreak® Vascular receive FDA 510(k) clearance?

SafeBreak® Vascular received FDA 510(k) clearance on 2023-05-19, under 510(k) number K223486.

Who is the listed applicant for SafeBreak® Vascular?

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

What is the FDA product code for SafeBreak® Vascular?

The FDA product code for SafeBreak® Vascular is QOI.

其他以 Lineus Medical 為申請人之記錄

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K231957SafeBreak® 頸動脈血管

相關器械（代碼：QOI）

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。

K241415Orchid 安全釋放閥™Linear Health Sciences, LLC K232094Orchid 安全釋放閥TMLinear Health Sciences, LLC K231957SafeBreak® 頸動脈血管Lineus Medical K230266蘭花安全釋放閥Linear Health Sciences, LLC K222791SafeBreak 頸動脈Lineus Medical, LLC K212064蘭花安全釋放閥（TM）Linear Health Sciences, LLC

官方來源

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