FDA 510(k)

Aventus凝血管理系统

K号: K240426 · 2024-05-14

决定日期2024-05-14

产品代码CAC

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决定实质等同

器械摘要

Aventus Clot Management System is the device name listed in this FDA 510(k) record. The listed applicant is Inquis Medical. It received FDA 510(k) clearance on 2024-05-14 under 510(k) number K240426. 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 Aventus Clot Management System?

Aventus Clot Management System is a medical device that received FDA 510(k) clearance on 2024-05-14. The listed applicant is Inquis Medical. The 510(k) number is K240426.

When did Aventus Clot Management System receive FDA 510(k) clearance?

Aventus Clot Management System received FDA 510(k) clearance on 2024-05-14, under 510(k) number K240426.

Who is the listed applicant for Aventus Clot Management System?

FDA 510(k)记录中列出Inquis Medical为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Aventus Clot Management System?

The FDA product code for Aventus Clot Management System is CAC.

列明Inquis Medical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。

K261105驱动 Avensus 血栓切除术系统™K262030Aventus血栓切除术系统 K260091Aventus introducer鞘 K253925Aventus血栓切除术系统 K251189Aventus血栓切除术系统 K250668Aventus血栓切除术系统 (IM-2100)

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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.K240584XTRA 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.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation 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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