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FDA 510(k)

stay•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

K 號：K250404 · 2025-04-03

申請人Fresenius Medical Care Renal Therapies Group, LLC
決定日期2025-04-03
產品代碼KDJ
諮詢委員會GU
決定相當於

器材摘要

stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch 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 2025-04-03 under 510(k) number K250404. 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 stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch?

stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250404.

When did stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch receive FDA 510(k) clearance?

stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch received FDA 510(k) clearance on 2025-04-03, under 510(k) number K250404.

Who is the listed applicant for stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch?

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 stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch?

The FDA product code for stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch 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。

K231849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, LLCK173651多管段組合設備，配備安全固定式PIN連接器，安全排液設備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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

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