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FDA 510(k)

翼型输液器，安全翼型输液器，血液采集套装，带夹血液采集套装，安全血液采集套装，带夹安全血液采集套装

K号: K232881 · 2023-12-22

申请人Jiangsu Kangbao Medical Equipment Co., Ltd.
决定日期2023-12-22
产品代码JKA
咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232881. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. The 510(k) number is K232881.

When did Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder receive FDA 510(k) clearance?

Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232881.

Who is the listed applicant for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

The FDA 510(k) record lists Jiangsu Kangbao Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder?

The FDA product code for Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder is JKA.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Jiangsu Kangbao Medical Equipment Co., Ltd.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。

K221247无菌一次性使用安全注射器，无菌一次性使用注射器，无菌一次性使用安全针，无菌一次性使用针K211329无菌一次性使用安全针，无菌一次性使用注射器，无菌一次性使用注射器，无菌一次性使用安全针，无菌一次性使用针K192681安全头皮静脉套件，头皮静脉套件，采血针（头皮静脉套件型），采血针（针夹型），安全采血针（头皮静脉套件型），安全采血针（针夹型）K182649带Enfit连接器的肠内营养注射器

相关器械（代码：JKA）

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。

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官方来源

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