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FDA 510(k)

CalliSpheres 脂肪栓塞微球，8Spheres 脂肪栓塞微球

K号: K173871 · 2018-09-17

申请人Suzhou Hengrui Callisyn Biomedical Co., Ltd.
决定日期2018-09-17
产品代码NAJ
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Callisyn Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-17 under 510(k) number K173871. The device is classified under product code NAJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is a medical device that received FDA 510(k) clearance on 2018-09-17. The listed applicant is Suzhou Hengrui Callisyn Biomedical Co., Ltd.. The 510(k) number is K173871.

When did CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres receive FDA 510(k) clearance?

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres received FDA 510(k) clearance on 2018-09-17, under 510(k) number K173871.

Who is the listed applicant for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?

The FDA 510(k) record lists Suzhou Hengrui Callisyn Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres?

The FDA product code for CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres is NAJ.

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

相关器械（代码：NAJ）

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。

K233813Bearing nsPVA Express™Merit Medical Systems, Inc.

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