FDA 510(k)

BardPort®、SlimPort® 和 X-Port® 埋入式端口

K号: K153359 · 2016-05-20

决定日期2016-05-20

产品代码LJT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

BardPort®, SlimPort®, and X-Port® Implanted Ports 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 2016-05-20 under 510(k) number K153359. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BardPort®, SlimPort®, and X-Port® Implanted Ports?

BardPort®, SlimPort®, and X-Port® Implanted Ports is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153359.

When did BardPort®, SlimPort®, and X-Port® Implanted Ports receive FDA 510(k) clearance?

BardPort®, SlimPort®, and X-Port® Implanted Ports received FDA 510(k) clearance on 2016-05-20, under 510(k) number K153359.

Who is the listed applicant for BardPort®, SlimPort®, and X-Port® Implanted Ports?

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 BardPort®, SlimPort®, and X-Port® Implanted Ports?

The FDA product code for BardPort®, SlimPort®, and X-Port® Implanted Ports is LJT.

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：LJT）

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。

K260916FLEXI-PORT® 动力注射植入式端口Portal Access, Inc.K252478Vaccess™ CT 低轮廓电力注射植入式端口；Vaccess™ CT 电力注射植入式端口；PowerPort™ duo M.R.I.™ 植入式端口Bard Access Systems, Inc.K251253PowerPort® isp 植入式端口；PowerPort® 超薄植入式端口；PowerPort® M.R.I.® 植入式端口；PowerPort® M.R.I.® isp 植入式端口Bard Access Systems, Inc.K242328PowerPort® ClearVUE® 超薄植入式端口和PowerPort® ClearVUE® 超薄植入式端口Bard Access Systems, Inc.K232737PowerPort® ClearVUE® 超薄心电图植入式端口；PowerPort® ClearVUE® isp 心电图植入式端口；PowerPort® isp M.R.I.® 心电图植入式端口；PowerPort® 超薄心电图植入式端口Bard Peripheral Vascular, Inc.K190559SmartPort+植入式端口，SmartPort塑料植入式端口AngioDynamics, Inc.

官方来源

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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。