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FDA 510(k)

多管段組合設備，配備安全固定式PIN連接器，安全排液設備

K 號：K173651 · 2018-02-14

申請人Fresenius Medical Care Renal Therapies Group, LLC
決定日期2018-02-14
產品代碼KDJ
諮詢委員會GU
決定相當於

器材摘要

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2018-02-14 under 510(k) number K173651. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is a medical device that received FDA 510(k) clearance on 2018-02-14. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173651.

When did Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set receive FDA 510(k) clearance?

Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set received FDA 510(k) clearance on 2018-02-14, under 510(k) number K173651.

Who is the listed applicant for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set?

The FDA product code for Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set is KDJ.

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 Fresenius Medical Care Renal Therapies Group, LLC 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。

K261267Careflux H60；Careflux H70；Careflux V500K252377NxStage System One 配 NxViewK252459multiFlux 130 (F00013123)；multiFlux 160 (F00013124)K253462NaturaLyte®乾性重碳濃縮液（08-4112-2）K253518FX珊瑚40；FX珊瑚50K250634BCM2-Body Composition Monitor

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相關器械（代碼：KDJ）

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。

K250404stay•safe® 腹腔鏈接延伸套件配 Safe-Lock，12 英寸；stay•safe® 腹腔鏈接延伸套件配 Luer-Lock，6 英寸；stay•safe® 腹腔鏈接延伸套件配 Luer-Lock，12 英寸；stay•safe® 腹腔鏈接延伸套件配 Luer-Lock，18 英寸；stay•safe® 至 Luer-Lock 轉接器，4 英寸Fresenius Medical Care Renal Therapies Group, LLCK231849迷你帽延長壽命PD傳輸組搭配扭結夾具 - 代號 5C4482A；迷你帽延長壽命PD傳輸組搭配扭結夾具 - 長度加短 - 代號 5C4483Baxter HealthcareK21401615L 循環器排液袋Baxter Healthcare CorporationK192705MiniCap Extended Life 腹膜透析傳輸套組Baxter HealthcareK173593安心安全針筒延伸套組配安全鎖，12英吋，安心安全針筒延伸套組配路艾式鎖，6英吋，安心安全針筒延伸套組配路艾式鎖，12英吋，安心安全針筒延伸套組配路艾式鎖，18英吋，安心安全至路艾式鎖轉接器，4英吋Fresenius Medical Care Renal Therapies Group, LLCK173363循環器排液袋組Fresenius Medical Care Renal Therapies Group, LLC

官方來源

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