FDA 510(k)

ClearLumen II 頸外血栓切除系統

K 號：K163051 · 2017-02-21

決定日期2017-02-21

產品代碼QEZ

諮詢委員會履歷

決定相當於

器材摘要

ClearLumen II Peripheral Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Walk Vascular, LLC. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K163051. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearLumen II Peripheral Thrombectomy System?

ClearLumen II Peripheral Thrombectomy System is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Walk Vascular, LLC. The 510(k) number is K163051.

When did ClearLumen II Peripheral Thrombectomy System receive FDA 510(k) clearance?

ClearLumen II Peripheral Thrombectomy System received FDA 510(k) clearance on 2017-02-21, under 510(k) number K163051.

Who is the listed applicant for ClearLumen II Peripheral Thrombectomy System?

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

What is the FDA product code for ClearLumen II Peripheral Thrombectomy System?

The FDA product code for ClearLumen II Peripheral Thrombectomy System is QEZ.

其他以 Walk Vascular, LLC 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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相關器械（代碼：QEZ）

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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