FDA 510(k)

選項 ELITE 靜脈閉塞器系統 (352506070E 352506100E)

K 號：K242612 · 2024-09-10

決定日期2024-09-10

產品代碼DTK

諮詢委員會履歷

決定相當於

器材摘要

Option ELITE Vena Cava Filter System (352506070E 352506100E) is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K242612. 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 Option ELITE Vena Cava Filter System (352506070E 352506100E)?

Option ELITE Vena Cava Filter System (352506070E 352506100E) is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Argon Medical Devices, Inc.. The 510(k) number is K242612.

When did Option ELITE Vena Cava Filter System (352506070E 352506100E) receive FDA 510(k) clearance?

Option ELITE Vena Cava Filter System (352506070E 352506100E) received FDA 510(k) clearance on 2024-09-10, under 510(k) number K242612.

Who is the listed applicant for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

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

What is the FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E)?

The FDA product code for Option ELITE Vena Cava Filter System (352506070E 352506100E) is DTK.

其他以 Argon Medical Devices, Inc. 為申請人之記錄

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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。

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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