FDA 510(k)

MiniCap延长寿命PD转移套装

K号: K192705 · 2019-10-25

决定日期2019-10-25

产品代码KDJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Baxter Healthcare为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K231849MiniCap延长寿命PD转移套装带旋转夹 - 编码5C4482A；MiniCap延长寿命PD转移套装带旋转夹 - 非常短 - 编码5C4483

相关器械（代码：KDJ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250404stay•safe® 安全锁定导尿管延长管套装，12英寸；stay•safe® Luer-Lock导尿管延长管套装，6英寸；stay•safe® Luer-Lock导尿管延长管套装，12英寸；stay•safe® Luer-Lock导尿管延长管套装，18英寸；stay•safe® 至 Luer-Lock 转换器，4英寸Fresenius Medical Care Renal Therapies Group, LLC K231849MiniCap延长寿命PD转移套装带旋转夹 - 编码5C4482A；MiniCap延长寿命PD转移套装带旋转夹 - 非常短 - 编码5C4483Baxter Healthcare K21401615L 循环器引流袋Baxter Healthcare Corporation K173593安全锁闭式留置导管延长管套装，12英寸，安全锁闭式留置导管延长管套装，6英寸，安全锁闭式留置导管延长管套装，12英寸，安全锁闭式留置导管延长管套装，18英寸，安全留置导管至Luer-Lock适配器，4英寸Fresenius Medical Care Renal Therapies Group, LLC K173651带安全PIN连接器的多管段套装，带安全引流套装Fresenius Medical Care Renal Therapies Group, LLC K173363Cycler引流袋套装Fresenius Medical Care Renal Therapies Group, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。