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FDA 510(k)

Günther 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）

K 號：K211874 · 2021-07-28

申請人William Cook Europe Aps
決定日期2021-07-28
產品代碼DTK
諮詢委員會履歷
決定相當於

器材摘要

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211874. 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 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach?

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is William Cook Europe Aps. The 510(k) number is K211874.

When did Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach receive FDA 510(k) clearance?

Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211874.

Who is the listed applicant for Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach?

The FDA 510(k) record lists William Cook Europe Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach?

The FDA product code for Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is DTK.

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 William Cook Europe Aps 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。

K251596Lunderquist 頗硬導絲指引K251499Frova 通氣導管引入器 (C-CAE-14.0-70-FII)；Frova 通氣導管引入器 (C-CAE-14.0-70-FI)；Frova 通氣導管引入器 (C-CAE-14.0-70-FIC)；Frova 通氣導管引入器 (C-CAE-14.0-70-FIC-SPOPS)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K220137Lunderquist 頗硬導絲指引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K171513Lunderquist 頗硬導絲指引

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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.K240578VenaTech® LP 靜脈腔隔離器系統及 VenaTech® 可轉換型靜脈腔隔離器系統B.Braun Medical, 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BdK233680Celect 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 ApsK211875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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