FDA 510(k)

MiniCap Extended Life 腹膜透析傳輸套組

K 號：K192705 · 2019-10-25

決定日期2019-10-25

產品代碼KDJ

諮詢委員會GU

決定相當於

器材摘要

MiniCap Extended Life PD Transfer Sets is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192705. 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 MiniCap Extended Life PD Transfer Sets?

MiniCap Extended Life PD Transfer Sets is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Baxter Healthcare. The 510(k) number is K192705.

When did MiniCap Extended Life PD Transfer Sets receive FDA 510(k) clearance?

MiniCap Extended Life PD Transfer Sets received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192705.

Who is the listed applicant for MiniCap Extended Life PD Transfer Sets?

The FDA 510(k) record lists Baxter Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniCap Extended Life PD Transfer Sets?

The FDA product code for MiniCap Extended Life PD Transfer Sets is KDJ.

其他以 Baxter Healthcare 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。

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 5C4483

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, LLC 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 Healthcare K21401615L 循環器排液袋Baxter Healthcare Corporation K173593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, LLC K173651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, LLC K173363循環器排液袋組Fresenius Medical Care Renal Therapies Group, LLC

官方來源

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