FDA 510(k)

Denali™ 靜脈閉塞器系統 – 髂總動脈及頸內/鎖骨下遞送套件

K 號：K240257 · 2024-02-29

申請人Bd

決定日期2024-02-29

產品代碼DTK

諮詢委員會履歷

決定相當於

器材摘要

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2024-02-29 under 510(k) number K240257. 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 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is a medical device that received FDA 510(k) clearance on 2024-02-29. The listed applicant is Bd. The 510(k) number is K240257.

When did Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit receive FDA 510(k) clearance?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit received FDA 510(k) clearance on 2024-02-29, under 510(k) number K240257.

Who is the listed applicant for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

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

What is the FDA product code for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

The FDA product code for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is DTK.

其他以 Bd 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。

K253445BD Surgiphor™ 1000 mL 抗菌灌洗系統 (910120)K232434BD Veritor™ 系統快速檢測流感A+B CLIA Waived Kit K223016BD Veritor™ 系統快速檢測流感A+B CLIA-Waived Kit K221504BD Surgiphor™ 抗菌灌洗系統 K180438BD Veritor 系統快速檢測流感 A + B CLIA 豁免套件

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.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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。