FDA 510(k)

文纳特克可转换下腔静脉滤器系统

K号: K152765 · 2016-02-26

申请人B. Braun Interventional Systems, Inc.

决定日期2016-02-26

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

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K152765. 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 VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K152765.

When did VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM receive FDA 510(k) clearance?

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM received FDA 510(k) clearance on 2016-02-26, under 510(k) number K152765.

Who is the listed applicant for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

The FDA 510(k) record lists B. Braun Interventional Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

The FDA product code for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is DTK.

列明B. Braun Interventional Systems, Inc.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。

K162625SeQuent Neo经皮腔内冠状动脉成形术（PTCA）球囊导管

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Bd 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William Cook Europe Aps K211874Günther 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 ApproachWilliam Cook Europe Aps

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