FDA 510(k)

福吉瑞透亮血栓切除导管

K 號：K240078 · 2024-08-28

決定日期2024-08-28

產品代碼DXE

諮詢委員會履歷

決定相當於

器材摘要

Fogarty Thru-Lumen Embolectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K240078. 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 Thru-Lumen Embolectomy Catheter?

Fogarty Thru-Lumen Embolectomy Catheter is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K240078.

When did Fogarty Thru-Lumen Embolectomy Catheter receive FDA 510(k) clearance?

Fogarty Thru-Lumen Embolectomy Catheter received FDA 510(k) clearance on 2024-08-28, under 510(k) number K240078.

Who is the listed applicant for Fogarty Thru-Lumen Embolectomy Catheter?

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

What is the FDA product code for Fogarty Thru-Lumen Embolectomy Catheter?

The FDA product code for Fogarty Thru-Lumen Embolectomy Catheter is DXE.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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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。

K241330福吉特強動脈血栓切除針Edwards Lifesciences K233820福吉藍動脈血栓切除針筒，配門閥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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