FDA 510(k)

SmartPort+植入式端口，SmartPort塑料植入式端口

K号: K190559 · 2020-05-22

决定日期2020-05-22

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

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K190559. 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 SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K190559.

When did SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports receive FDA 510(k) clearance?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports received FDA 510(k) clearance on 2020-05-22, under 510(k) number K190559.

Who is the listed applicant for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

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

What is the FDA product code for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

The FDA product code for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is LJT.

列明AngioDynamics, 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。

K252509AlphaVac 多用途机械吸引系统 F1885 K253106AngioVac 管道 K242687NanoKnife发生器（H78720300301US0）；NanoKnife单电极激活探头，15厘米（H787204001090）；NanoKnife单电极激活探头，25厘米（H787204001100）；NanoKnife单电极探头间隔器（H787204003010）K240397AlphaVac MMA F1885 系统（H787253020）K231945VenaCure EVLT NeverTouch 手术套装；VenaCure EVLT NeverTouch 直接手术套装 K223581Solero 微波组织消融（MTA）系统及配件

查看所有 28 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.K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.

官方来源

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