FDA 510(k)

天一體外血液管路組合套件 (TY-NDEO-A1)

K 號：K251442 · 2025-10-02

申請人Ningbo Tianyi Medical Appliance Co., Ltd.

決定日期2025-10-02

產品代碼FJK

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Ningbo Tianyi Medical Appliance Co., Ltd. 為申請人之記錄

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相關器械（代碼：FJK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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