FDA 510(k)

SelectFlex 072 神經血管進入系統

K 號：K181000 · 2018-09-13

申請人Q'Apel

決定日期2018-09-13

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

SelectFlex 072 Neurovascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K181000. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SelectFlex 072 Neurovascular Access System?

SelectFlex 072 Neurovascular Access System is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Q'Apel. The 510(k) number is K181000.

When did SelectFlex 072 Neurovascular Access System receive FDA 510(k) clearance?

SelectFlex 072 Neurovascular Access System received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181000.

Who is the listed applicant for SelectFlex 072 Neurovascular Access System?

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

What is the FDA product code for SelectFlex 072 Neurovascular Access System?

The FDA product code for SelectFlex 072 Neurovascular Access System is DQY.

其他以 Q'Apel 為申請人之記錄

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K190749087 機械導管系統

相關器械（代碼：DQY）

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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