FDA 510(k)

Aventus 靈栓切除系統 (IM-2001/IM-0002)

K 號：K240117 · 2024-03-15

決定日期2024-03-15

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

Aventus Thrombectomy System (IM-2001/IM-0002) is the device name listed in this FDA 510(k) record. The listed applicant is Inquis Medical. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K240117. 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 Aventus Thrombectomy System (IM-2001/IM-0002)?

Aventus Thrombectomy System (IM-2001/IM-0002) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Inquis Medical. The 510(k) number is K240117.

When did Aventus Thrombectomy System (IM-2001/IM-0002) receive FDA 510(k) clearance?

Aventus Thrombectomy System (IM-2001/IM-0002) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240117.

Who is the listed applicant for Aventus Thrombectomy System (IM-2001/IM-0002)?

FDA 510(k) 記錄將 Inquis Medical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aventus Thrombectomy System (IM-2001/IM-0002)?

The FDA product code for Aventus Thrombectomy System (IM-2001/IM-0002) is QEW.

其他以 Inquis Medical 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。

K261105驅動Aventus血栓切除系統™K262030Aventus 靈栓切除系統 K260091Aventus 引入鞘 K253925Aventus 靈栓切除系統 K251189Aventus 靈栓切除系統 K250668Aventus 靈栓切除系統 (IM-2100)

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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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