FDA 510(k)

Cobra 管導系統

K 號：K223891 · 2023-02-15

決定日期2023-02-15

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

Cobra Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Endovascular Engineering. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K223891. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cobra Catheter System?

Cobra Catheter System is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Endovascular Engineering. The 510(k) number is K223891.

When did Cobra Catheter System receive FDA 510(k) clearance?

Cobra Catheter System received FDA 510(k) clearance on 2023-02-15, under 510(k) number K223891.

Who is the listed applicant for Cobra Catheter System?

FDA 510(k)記錄將內血管工程列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for Cobra Catheter System?

The FDA product code for Cobra Catheter System is QEW.

其他以 Endovascular Engineering 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。

K261800Helo Max 靈栓切除系統 (HEL2090)

相關器械（代碼：QEW）

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。

K253419Triever Duo 穿刺針管Inari Medical, Inc.K261800Helo Max 靈栓切除系統 (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ 靈栓切除系統Jupiter Endovascular K260599INDIGO® 吸引系統 – INDIGO 鏈接Penumbra, Inc.K251949INDIGO® 吸引系統 - 雷電閃吸管連結版Penumbra, Inc.

官方來源

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