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FDA 510(k)

NovaLine 血液透析管路組 (BL 124)

K 號：K252423 · 2026-05-15

申請人Bain Medical Equipment (Guangzhou) Co., Ltd.
決定日期2026-05-15
產品代碼FJK
諮詢委員會GU
決定相當於

器材摘要

NovaLine Tubing Set for Hemodialysis (BL 124) is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K252423. 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 NovaLine Tubing Set for Hemodialysis (BL 124)?

NovaLine Tubing Set for Hemodialysis (BL 124) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K252423.

When did NovaLine Tubing Set for Hemodialysis (BL 124) receive FDA 510(k) clearance?

NovaLine Tubing Set for Hemodialysis (BL 124) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K252423.

Who is the listed applicant for NovaLine Tubing Set for Hemodialysis (BL 124)?

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

What is the FDA product code for NovaLine Tubing Set for Hemodialysis (BL 124)?

The FDA product code for NovaLine Tubing Set for Hemodialysis (BL 124) is FJK.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Bain Medical Equipment (Guangzhou) Co., Ltd. 為申請人之記錄

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。

K240164NovaLine SP-C35 超聲波傳感器保護器（956007）K213015DORA一次性A.V.動脈針套組K201866NovaLine 血液透析管路套件K203524外科口罩K163025DORA一次性A.V.動脈針套組K161582DORA 血液透析管路套件

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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。

K251341VITAL 血液透析管路套件Vital Healthcare Sdn. Bhd.K251442天一體外血液管路組合套件 (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K243607Moda-flx 靜脈透析系統™ 製劑 (102121-001)Diality, Inc.K213992CombiSet 靜脈透析血液管路組Fresenius Medical Care Renal Therapies Group, LLCK210782Tablo 壳蓋Outset Medical, Inc.K202796SANSIN 血液透析管路套件Jiangxi Sanxin Medtec Co., Ltd.

官方來源

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