FDA 510(k)

Kurin高压PIV血液收集套装

K号: K181895 · 2019-01-18

决定日期2019-01-18

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

Kurin PIV Blood Collection Set with High Pressure is the device name listed in this FDA 510(k) record. The listed applicant is Kurin, Inc.. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K181895. 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 Kurin PIV Blood Collection Set with High Pressure?

Kurin PIV Blood Collection Set with High Pressure is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is Kurin, Inc.. The 510(k) number is K181895.

When did Kurin PIV Blood Collection Set with High Pressure receive FDA 510(k) clearance?

Kurin PIV Blood Collection Set with High Pressure received FDA 510(k) clearance on 2019-01-18, under 510(k) number K181895.

Who is the listed applicant for Kurin PIV Blood Collection Set with High Pressure?

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

What is the FDA product code for Kurin PIV Blood Collection Set with High Pressure?

The FDA product code for Kurin PIV Blood Collection Set with High Pressure is JKA.

列明Kurin, 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。

K220677Kurin血液培养收集套装带Kurin锁技术 K191832Kurin血液培养收集套装带Kurin锁技术，推钮式针头（产品型号M-21221, M-21223, D-21221, D-21223, T-21221, T-21223）

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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