FDA 510(k)

TIANYI体外循环血管套装（TY-NDEO-A1）

K号: K251442 · 2025-10-02

申请人Ningbo Tianyi Medical Appliance Co., Ltd.

决定日期2025-10-02

产品代码FJK

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决定实质等同

器械摘要

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K251442. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Ningbo Tianyi Medical Appliance Co., Ltd.. The 510(k) number is K251442.

When did TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) receive FDA 510(k) clearance?

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) received FDA 510(k) clearance on 2025-10-02, under 510(k) number K251442.

Who is the listed applicant for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

The FDA 510(k) record lists Ningbo Tianyi Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

The FDA product code for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is FJK.

列明Ningbo Tianyi Medical Appliance Co., Ltd.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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