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FDA 510(k)

Aspire MAX 7 - 11F 體外血凝機系統及 Aspire 體外吸引器

K 號：K200871 · 2020-05-04

申請人Control Medical Technology
決定日期2020-05-04
產品代碼QEZ
諮詢委員會履歷
決定相當於

器材摘要

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator is the device name listed in this FDA 510(k) record. The listed applicant is Control Medical Technology. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K200871. 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 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator?

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Control Medical Technology. The 510(k) number is K200871.

When did Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator receive FDA 510(k) clearance?

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator received FDA 510(k) clearance on 2020-05-04, under 510(k) number K200871.

Who is the listed applicant for Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator?

The FDA 510(k) record lists Control Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator?

The FDA product code for Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator is QEZ.

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 Control Medical Technology 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。

K200629Aspire 體外吸引器 G

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。

K254035Mayumi™ 靈活血栓切除系統MicroVention, Inc., d/b/a Terumo NeuroK261105驅動Aventus血栓切除系統™Inquis MedicalK262030Aventus 靈栓切除系統Inquis MedicalK253589Liberant™ RX 吸引針管Medtronic Interventional Vascular, Inc.K254208FLOWRUNNER 吸引系統Expanse Medical, Inc.K253925Aventus 靈栓切除系統Inquis Medical

官方來源

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