FDA 510(k)

SelectFlex神經血管通路系統家族

K 號：K230322 · 2023-06-22

決定日期2023-06-22

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

SelectFlex Neurovascular Access System Family is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K230322. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SelectFlex Neurovascular Access System Family?

SelectFlex Neurovascular Access System Family is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Q'Apel Medical, Inc.. The 510(k) number is K230322.

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

SelectFlex Neurovascular Access System Family received FDA 510(k) clearance on 2023-06-22, under 510(k) number K230322.

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

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

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

The FDA product code for SelectFlex Neurovascular Access System Family is QJP.

其他以 Q'Apel Medical, Inc. 為申請人之記錄

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相關器械（代碼：QJP）

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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