FDA 510(k)

HydroMID

K号: K203069 · 2021-02-08

决定日期2021-02-08

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

HydroMID 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 2021-02-08 under 510(k) number K203069. 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?

HydroMID is a medical device that received FDA 510(k) clearance on 2021-02-08. The listed applicant is Access Vascular, Inc.. The 510(k) number is K203069.

When did HydroMID receive FDA 510(k) clearance?

HydroMID received FDA 510(k) clearance on 2021-02-08, under 510(k) number K203069.

Who is the listed applicant for HydroMID?

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?

The FDA product code for HydroMID is FOZ.

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。

K243458HydroPICC 4Fr 单腔标记导管，130 cm 导丝 - 基础套装 (70001301)；HydroPICC 4Fr 单腔标记导管，70 cm 导丝 - 基础套装 (70001302)；HydroPICC 4Fr 单腔标记导管 - 最大屏障套装 (70001304)；HydroPICC 5Fr 双腔标记导管，130 cm 导丝 - 基础套装 (70002301)；HydroPICC 5Fr 双腔标记导管，70 cm 导丝 - 基础套装 (70002302)；HydroPICC 5Fr 双腔标记导管 - 最大屏障套装 (70002304)；Hydr K251212双腔5Fr HydroPICC导管（PICC-251CM）（PICC-251CM）；双腔5Fr HydroPICC导管（PICC-252CM）（PICC-252CM）K244059HydroMID 5F 双腔中线导管 - 基础套装 (70006102)；HydroMID 5F 双腔中线导管 - 最大屏障套装 (70006104)；HydroMID 5F 双腔中线导管 - 移动最大屏障套装 (90006104)K243941HydroPICC 4Fr 单腔标记导管，130 cm 导丝 - 基础套装 (70001201)；HydroPICC 4Fr 单腔标记导管，70 cm 导丝 - 基础套装 (70001202)；HydroPICC 4Fr 单腔标记导管，最大屏障套装 (70001204)；HydroPICC 4Fr 单腔标记导管，移动最大屏障套装 (90001204)K220772HydroMID 4F 单腔中线导管 K213550HydroPICC 5F 双腔导管

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官方来源

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