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FDA 510(k)

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

K号: K211874 · 2021-07-28

申请人William Cook Europe Aps
决定日期2021-07-28
产品代码DTK
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明William Cook Europe Aps为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251596Lunderquist 额外硬质导丝K251499Frova插管引导器（C-CAE-14.0-70-FII）；Frova插管引导器（C-CAE-14.0-70-FI）；Frova插管引导器（C-CAE-14.0-70-FIC）；Frova插管引导器（C-CAE-14.0-70-FIC-SPOPS）K233680Celect Platinum 股静脉滤器套装 (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum 颈静脉滤器套装 (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum 股静脉和颈静脉滤器套装 (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip 股静脉滤器套装 (IGTCFS-65-1-FEM-TULIP); Günther Tulip 颈静脉滤器套装 (IGTCFS-65-1-JUG-TULIP); Günther Tulip 静脉滤器K220137Lunderquist 额外硬质导丝K211875Cook Celect Platinum 股静脉途径下腔静脉滤器套装，Cook Celect Platinum 颈静脉途径下腔静脉滤器套装，Cook Celect Platinum 股静脉和颈静脉途径下腔静脉滤器套装K171513Lunderquist 额外硬质导丝

查看所有 11 个设备 →

相关器械（代码：DTK）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242612Option ELITE 下腔静脉滤过系统 (352506070E 352506100E)Argon Medical Devices, Inc.K240578VenaTech® LP 腔静脉滤器系统和 VenaTech® 可转换腔静脉滤器系统B.Braun Medical, Inc.K241507ALN 可选下腔静脉滤器 (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ 下腔静脉滤过系统 – 髂股部和颈静脉/锁骨下输送套件BdK233680Celect Platinum 股静脉滤器套装 (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum 颈静脉滤器套装 (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum 股静脉和颈静脉滤器套装 (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip 股静脉滤器套装 (IGTCFS-65-1-FEM-TULIP); Günther Tulip 颈静脉滤器套装 (IGTCFS-65-1-JUG-TULIP); Günther Tulip 静脉滤器William Cook Europe ApsK211875Cook Celect Platinum 股静脉途径下腔静脉滤器套装，Cook Celect Platinum 颈静脉途径下腔静脉滤器套装，Cook Celect Platinum 股静脉和颈静脉途径下腔静脉滤器套装William Cook Europe Aps

官方来源

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