15L 循環器排液袋
K 號：K214016 · 2022-03-18
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器材摘要
15L Cycler Drainage Bag is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K214016. 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 15L Cycler Drainage Bag?
15L Cycler Drainage Bag is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K214016.
When did 15L Cycler Drainage Bag receive FDA 510(k) clearance?
15L Cycler Drainage Bag received FDA 510(k) clearance on 2022-03-18, under 510(k) number K214016.
Who is the listed applicant for 15L Cycler Drainage Bag?
The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 15L Cycler Drainage Bag?
The FDA product code for 15L Cycler Drainage Bag is KDJ.
相關臨床試驗
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其他以 Baxter Healthcare Corporation 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。
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 HealthcareK192705MiniCap 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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