Pro-Lock CT 安全输液器
K号: K162271 · 2017-04-26
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决定日期2017-04-26
产品代码PTI
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
Pro-Lock CT Safety Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K162271. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pro-Lock CT Safety Infusion Set?
Pro-Lock CT Safety Infusion Set is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K162271.
When did Pro-Lock CT Safety Infusion Set receive FDA 510(k) clearance?
Pro-Lock CT Safety Infusion Set received FDA 510(k) clearance on 2017-04-26, under 510(k) number K162271.
Who is the listed applicant for Pro-Lock CT Safety Infusion Set?
The FDA 510(k) record lists Medcomp (Medical Components, Inc.) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pro-Lock CT Safety Infusion Set?
The FDA product code for Pro-Lock CT Safety Infusion Set is PTI.
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, 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。
相关器械（代码：PTI）
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。
K25409525G 胡贝尔针Martech Medical ProductsK252355K-SHIELD Advantage PORT ACCESS INFUSION SET 带高压软管Sb-Kawasumi Laboratories, Inc.K251138Promisemed 安全胡伯针Promisemed Hangzhou Meditech Co., Ltd.K243332Promisemed 安全胡伯针Promisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max 动力注射输液套件；SafeStep™ Huber 针头套件Bard Access Systems, Inc.K230715Promisemed 安全胡伯针Promisemed Hangzhou Meditech Co., Ltd.
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。
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