Dignity双通道
K号: K153238 · 2016-03-15
广告
决定日期2016-03-15
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
Dignity Dual Port is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp ( Medical Components). It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K153238. 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 Dignity Dual Port?
Dignity Dual Port is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Medcomp ( Medical Components). The 510(k) number is K153238.
When did Dignity Dual Port receive FDA 510(k) clearance?
Dignity Dual Port received FDA 510(k) clearance on 2016-03-15, under 510(k) number K153238.
Who is the listed applicant for Dignity Dual Port?
The FDA 510(k) record lists Medcomp ( Medical Components) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dignity Dual Port?
The FDA product code for Dignity Dual Port is LJT.
相关临床试验
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。
列明Medcomp ( Medical Components)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。
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
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。
广告