FDA 510(k)

JETi 頸外血栓切除系統

K 號：K192439 · 2019-12-09

決定日期2019-12-09

產品代碼QEZ

諮詢委員會履歷

決定相當於

器材摘要

JETi 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 2019-12-09 under 510(k) number K192439. 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 JETi Peripheral Thrombectomy System?

JETi Peripheral Thrombectomy System is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Walk Vascular, LLC. The 510(k) number is K192439.

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

JETi Peripheral Thrombectomy System received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192439.

Who is the listed applicant for JETi 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 JETi Peripheral Thrombectomy System?

The FDA product code for JETi 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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