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FDA 510(k)

MiniGuard 頸動安全閥

K 號：K182442 · 2018-11-06

申請人Quest Medical, Inc.
決定日期2018-11-06
產品代碼MJJ
諮詢委員會履歷
決定相當於

器材摘要

MiniGuard Arterial Safety Valve is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K182442. The device is classified under product code MJJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MiniGuard Arterial Safety Valve?

MiniGuard Arterial Safety Valve is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Quest Medical, Inc.. The 510(k) number is K182442.

When did MiniGuard Arterial Safety Valve receive FDA 510(k) clearance?

MiniGuard Arterial Safety Valve received FDA 510(k) clearance on 2018-11-06, under 510(k) number K182442.

Who is the listed applicant for MiniGuard Arterial Safety Valve?

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

What is the FDA product code for MiniGuard Arterial Safety Valve?

The FDA product code for MiniGuard Arterial Safety Valve is MJJ.

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其他以 Quest Medical, 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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