primeMidline 导管
K号: K192802 · 2019-10-28
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决定日期2019-10-28
产品代码PND
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
primeMidline Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2019-10-28 under 510(k) number K192802. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the primeMidline Catheters?
primeMidline Catheters is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K192802.
When did primeMidline Catheters receive FDA 510(k) clearance?
primeMidline Catheters received FDA 510(k) clearance on 2019-10-28, under 510(k) number K192802.
Who is the listed applicant for primeMidline Catheters?
The FDA 510(k) record lists Pfm Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for primeMidline Catheters?
The FDA product code for primeMidline Catheters is PND.
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Pfm Medical, 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：PND）
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。
K252402中线导管Terumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow 压力注射中线导管Arrow International, LLC Subsidiary of Teleflex IncorporatedK213203Provena™ 中线导管C.R. Bard, Inc.K210047Stiletto 延长停留导管Piper Access, LLCK181208Vygon 中线 3 Fr SL 管道；Vygon 中线 4 Fr SL 管道；Vygon 中线 5 Fr DL 管道Vygon USAK173114primeMidline 导管Pfm Medical, 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。
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