FDA 510(k)

Denali滤过系统 - 髂股部输送套件，Denali滤过系统 - 颈静脉/锁骨下输送套件

K号: K160866 · 2016-04-29

决定日期2016-04-29

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

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160866. 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 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit?

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K160866.

When did Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit receive FDA 510(k) clearance?

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160866.

Who is the listed applicant for Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit?

The FDA product code for Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit is DTK.

列明C.R. Bard, 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。

K253514明尼苏达四腔食管胃填塞管 - 18 French (0092220)；布莱克莫尔食管鼻胃管 - 20 French (0092100)；布莱克莫尔食管鼻胃管 - 16 French (0092300)K254076BD Touchless™ Plus 男女通用预润滑尿道导管套装 K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864橡胶通用导管 K251186Bard® 临时起搏电极导管针/管 (引入器)K241334半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，4Fr.（006221P）；半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，5Fr.（006225P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，6Fr.（006241P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，7Fr.（006242P）；NBIH™临时起搏电极导管

查看所有 67 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 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William Cook Europe Aps

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。