FDA 510(k)

福吉藍動脈血栓切除針筒，配門閥

K 號：K233820 · 2024-05-22

決定日期2024-05-22

產品代碼DXE

諮詢委員會履歷

決定相當於

器材摘要

Fogarty Arterial Embolectomy Catheter with Gate Valve is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K233820. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fogarty Arterial Embolectomy Catheter with Gate Valve?

Fogarty Arterial Embolectomy Catheter with Gate Valve is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Edwards Lifesciences. The 510(k) number is K233820.

When did Fogarty Arterial Embolectomy Catheter with Gate Valve receive FDA 510(k) clearance?

Fogarty Arterial Embolectomy Catheter with Gate Valve received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233820.

Who is the listed applicant for Fogarty Arterial Embolectomy Catheter with Gate Valve?

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

What is the FDA product code for Fogarty Arterial Embolectomy Catheter with Gate Valve?

The FDA product code for Fogarty Arterial Embolectomy Catheter with Gate Valve is DXE.

其他以 Edwards Lifesciences 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。

K254232ECLIPTIS 左心房顯影囊排除系統 (ECS135)；ECLIPTIS 左心房顯影囊排除系統 (ECS140)；ECLIPTIS 左心房顯影囊排除系統 (ECS145)；ECLIPTIS 左心房顯影囊排除系統 (ECS150)K260105Fogarty 強力夾釘，無把柄夾具，及夾具插片 K254279愛德華eSheath+ 引導套組 K252533HemoSphere Alta先進監控平台（ALTAALL1；ALTACR1；ALTASR1）K253034HemoSphere 流模組 K252364愛德華eSheath Optima引導套件

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相關器械（代碼：DXE）

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。

K240078福吉瑞透亮血栓切除导管Edwards Lifesciences, LLC K241330福吉特強動脈血栓切除針Edwards Lifesciences K233819福吉藍靜脈血栓切除針管Edwards Lifesciences, LLC K233619福吉蒂螺旋导管；福吉蒂移植物血栓切除导管Edwards Lifesciences K213771梅林吸引系統Mivi Neurovascular, Inc.K202049Python 腹腔鏈接器/導絲 Latis 節理清潔導管Applied Medical Resources Corporation

官方來源

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