FDA 510(k)

VenaTech® LP 靜脈腔隔離器系統及 VenaTech® 可轉換型靜脈腔隔離器系統

K 號：K240578 · 2024-07-31

決定日期2024-07-31

產品代碼DTK

諮詢委員會履歷

決定相當於

器材摘要

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K240578. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System?

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K240578.

When did VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System receive FDA 510(k) clearance?

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System received FDA 510(k) clearance on 2024-07-31, under 510(k) number K240578.

Who is the listed applicant for VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System?

FDA 510(k) 記錄將 B.Braun Medical, 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 VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System?

The FDA product code for VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System is DTK.

其他以 B.Braun 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。

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相關器械（代碼：DTK）

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。

K242612選項 ELITE 靜脈閉塞器系統 (352506070E 352506100E)Argon Medical Devices, Inc.K241507ALN 選擇性腹腔静脉過濾器 (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ 靜脈閉塞器系統 – 髂總動脈及頸內/鎖骨下遞送套件Bd K233680Celect 銀河 Vena Cava 過濾器組合用於股動脈進入法（IGTCFS-65-1-FEM-CELECT-PT）；Celect 銀河 Vena Cava 過濾器組合用於頸內動脈進入法（IGTCFS-65-1-JUG-CELECT-PT）；Celect 銀河 Vena Cava 過濾器組合用於股動脈及頸內動脈進入法（IGTCFS-65-1-UNI-CELECT-PT）；Günther Tulip Vena Cava 過濾器組合用於股動脈進入法（IGTCFS-65-1-FEM-TULIP）；Günther Tulip Vena Cava 過濾器組合用於頸內動脈進入法（IGTCFS-65-1-JUG-TULIP）；Günther Tulip Vena Cava 過濾器William Cook Europe Aps K211874Günther Tulip 靜脈腔隔離器組（股動脈進路用）、Günther Tulip 靜脈腔隔離器組（頸內動脈進路用）、Günther Tulip 靜脈腔隔離器組（股動脈及頸內動脈進路用）William Cook Europe Aps K211875庫克Celect Platinum 靜脈閉塞器組合用於股動脈進路，庫克Celect Platinum 靜脈閉塞器組合用於頸內動脈進路，庫克Celect Platinum 靜脈閉塞器組合用於股動脈及頸內動脈進路William Cook Europe Aps

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