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FDA 510(k)

Symphony™ 靈栓切除系統及 Symphony™ 16F 82cm 靈栓切除系統

K 號：K252057 · 2025-08-28

申請人Imperative Care, Inc.
決定日期2025-08-28
產品代碼QEW
諮詢委員會履歷
決定相當於

器材摘要

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252057. 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 Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System?

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Imperative Care, Inc.. The 510(k) number is K252057.

When did Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System receive FDA 510(k) clearance?

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252057.

Who is the listed applicant for Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System?

FDA 510(k) 記錄將 Imperative Care, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System?

The FDA product code for Symphony™ Thrombectomy System and Symphony™ 16F 82cm 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

其他以 Imperative Care, Inc. 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。

K261176Zoom 4S 管針K252046Zoom 系統（Zoom 4S 穿刺針）K244061X-Wire 導絲K243047Zoom 7X 管子；Zoom 吸引管；Zoom POD 吸引管K250775Symphony™ 靈栓切除系統；Symphony™ 16F 82cm 靈栓切除系統K242672縮放系統

查看所有 18 項裝置 →

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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