FDA 510(k)

PowerLoc™ Max 动力注射输液套件；SafeStep™ Huber 针头套件

K号: K241353 · 2024-11-27

决定日期2024-11-27

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

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K241353. 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 PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K241353.

When did PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set receive FDA 510(k) clearance?

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set received FDA 510(k) clearance on 2024-11-27, under 510(k) number K241353.

Who is the listed applicant for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA product code for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is PTI.

列明Bard Access Systems, 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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官方来源

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