FDA 510(k)

Nautilus VF ECMO Oxygenator

K号: K232767 · 2023-10-04

决定日期2023-10-04

产品代码BYS

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

Nautilus VF ECMO Oxygenator is the device name listed in this FDA 510(k) record. The listed applicant is Mc3, Inc.. It received FDA 510(k) clearance on 2023-10-04 under 510(k) number K232767. The device is classified under product code BYS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nautilus VF ECMO Oxygenator?

Nautilus VF ECMO Oxygenator is a medical device that received FDA 510(k) clearance on 2023-10-04. The listed applicant is Mc3, Inc.. The 510(k) number is K232767.

When did Nautilus VF ECMO Oxygenator receive FDA 510(k) clearance?

Nautilus VF ECMO Oxygenator received FDA 510(k) clearance on 2023-10-04, under 510(k) number K232767.

Who is the listed applicant for Nautilus VF ECMO Oxygenator?

The FDA 510(k) record lists Mc3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nautilus VF ECMO Oxygenator?

The FDA product code for Nautilus VF ECMO Oxygenator is BYS.

列明Mc3, Inc.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。

K203409MC3 Crescent 颈静脉双腔导管

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