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FDA 510(k)

Ellipsys血管通路系統（Ellipsys系統），功率控制器，Ellipsys血管通路系統（Ellipsys系統），導管，Ellipsys血管通路系統（Ellipsys系統），穿剌針

K 號：K183615 · 2019-01-25

申請人Avenu Medical, Inc.
決定日期2019-01-25
產品代碼PQK
諮詢委員會履歷
決定相當於

器材摘要

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle is the device name listed in this FDA 510(k) record. The listed applicant is Avenu Medical, Inc.. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K183615. The device is classified under product code PQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Avenu Medical, Inc.. The 510(k) number is K183615.

When did Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle receive FDA 510(k) clearance?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle received FDA 510(k) clearance on 2019-01-25, under 510(k) number K183615.

Who is the listed applicant for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle?

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

What is the FDA product code for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle?

The FDA product code for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle is PQK.

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 Avenu Medical, 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。

K181725Ellipsys血管通路系統（Ellipsys系統），（功率控制器型號AMi-1001及導管與針型號AMi-6005）

相關器械（代碼：PQK）

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。

K192239WavelinQ Plus內腎動脈分流系統C.R. Bard, Inc.K191114Ellipsys血管通路系統（Ellipsys系統），功率控制器，Ellipsys血管通路系統（Ellipsys系統），導管，Ellipsys血管通路系統（Ellipsys系統），針頭Avenu MedicalK182796WavelinQ 4F內腎動脈分流系統C.R. Bard, Inc.K181725Ellipsys血管通路系統（Ellipsys系統），（功率控制器型號AMi-1001及導管與針型號AMi-6005）Avenu Medical, Inc.

官方來源

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