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FDA 510(k)

PIVO® Pro 无针血液采集装置

K号: K230865 · 2023-09-28

申请人Becton Dickinson Infusion Therapy Systems, Inc.
决定日期2023-09-28
产品代码JKA
咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

PIVO™ Pro Needle-free Blood Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K230865. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PIVO™ Pro Needle-free Blood Collection Device?

PIVO™ Pro Needle-free Blood Collection Device is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K230865.

When did PIVO™ Pro Needle-free Blood Collection Device receive FDA 510(k) clearance?

PIVO™ Pro Needle-free Blood Collection Device received FDA 510(k) clearance on 2023-09-28, under 510(k) number K230865.

Who is the listed applicant for PIVO™ Pro Needle-free Blood Collection Device?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIVO™ Pro Needle-free Blood Collection Device?

The FDA product code for PIVO™ Pro Needle-free Blood Collection Device is JKA.

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列明Becton Dickinson Infusion Therapy Systems, Inc.为申报人的其他记录

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相关器械（代码：JKA）

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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