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FDA 510(k)

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

K号: K221722 · 2022-11-15

申请人Haemonetics Corporation
决定日期2022-11-15
产品代码CAC
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K221722. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Haemonetics Corporation. The 510(k) number is K221722.

When did Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) receive FDA 510(k) clearance?

Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) received FDA 510(k) clearance on 2022-11-15, under 510(k) number K221722.

Who is the listed applicant for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

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

What is the FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)?

The FDA product code for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) is CAC.

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Haemonetics Corporation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。

K243858TEG 6s 止血系统 柠檬酸盐：K, KH, RT, FF 测定卡K232018Citrated: K, KH, RTH, FFHK183160TEG 6s 止血系统，TEG 6s 柠檬酸盐：K, RT, FF 测定卡K160502TEG 6s 止血系统K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemK160197Haemonetics Cell Saver Elite Autotransfusion System

查看所有 7 个设备 →

相关器械（代码：CAC）

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。

K241236XTRA系列套装；XTRA隔离套装Sorin Group Italia S.R.L.K240426Aventus凝血管理系统Inquis MedicalK240584XTRA 自动输血系统（含 XTRA 碗套装）Sorin Group Italia S.R.L.K231782FlowSaver 血液回输系统 (80-101)Inari Medical, Inc.K221483FlowSaver 血液回输系统Inari Medical, Inc.K201305自动输血（ATS）胸腔引流管：海洋水封胸腔引流管，Oasis 干式吸引水封胸腔引流管，Express 干式密封胸腔引流管Atrium Medical Corporation

官方来源

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