HydroMID 4F 单腔中线导管
K号: K220772 · 2022-12-07
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决定日期2022-12-07
产品代码FOZ
咨询委员会医疗设备监管文本翻译如下：
HO
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决定实质等同
器械摘要
HydroMID 4F Single Lumen Midline Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Access Vascular, Inc.. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K220772. 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 HydroMID 4F Single Lumen Midline Catheter?
HydroMID 4F Single Lumen Midline Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Access Vascular, Inc.. The 510(k) number is K220772.
When did HydroMID 4F Single Lumen Midline Catheter receive FDA 510(k) clearance?
HydroMID 4F Single Lumen Midline Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K220772.
Who is the listed applicant for HydroMID 4F Single Lumen Midline Catheter?
The FDA 510(k) record lists Access Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HydroMID 4F Single Lumen Midline Catheter?
The FDA product code for HydroMID 4F Single Lumen Midline Catheter is FOZ.
相关临床试验
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列明Access Vascular, 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。
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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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