ViaValve 安全静脉导管
K号: K160235 · 2016-06-30
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决定日期2016-06-30
产品代码FOZ
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
ViaValve Safety I.V. Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K160235. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ViaValve Safety I.V. Catheter?
ViaValve Safety I.V. Catheter is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K160235.
When did ViaValve Safety I.V. Catheter receive FDA 510(k) clearance?
ViaValve Safety I.V. Catheter received FDA 510(k) clearance on 2016-06-30, under 510(k) number K160235.
Who is the listed applicant for ViaValve Safety I.V. Catheter?
The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ViaValve Safety I.V. Catheter?
The FDA product code for ViaValve Safety I.V. Catheter is FOZ.
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Smiths Medical Asd, 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。
K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeK210833Portex BLUxl 长型气管切开管，BLUxl 吸痰辅助长型气管切开管，BLUxl 长型气管切开管内芯K211634Hypodermic Needle-Pro EDGE Safety DeviceK192375Intellifuse给药和Intellifuse血液给药套装K181699Level 1对流加热器K172800Portex® Lancet Point 脊髓穿刺针带NRFit®连接器，Portex® Pencil Point 脊髓穿刺针带NRFit®连接器
相关器械（代码：FOZ）
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。
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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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