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FDA 510(k)

Laguna™ 血栓回收系統及Malibu™ 吸引導管系統（Laguna 靜脈血栓切除系統）

K 號：K223929 · 2023-06-01

申請人Innova Vascular, Inc.
決定日期2023-06-01
產品代碼QEW
諮詢委員會履歷
決定相當於

器材摘要

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vascular, Inc.. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K223929. 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 Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)?

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Innova Vascular, Inc.. The 510(k) number is K223929.

When did Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) receive FDA 510(k) clearance?

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K223929.

Who is the listed applicant for Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)?

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

What is the FDA product code for Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)?

The FDA product code for Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is QEW.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 EngineeringK262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ 靈栓切除系統Jupiter EndovascularK260599INDIGO® 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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