FDA 510(k)

Terumo 先进灌注系统 1

K号: K221895 · 2023-04-18

申请人Terumo Cardiovascular Systems Corporation

决定日期2023-04-18

产品代码DTQ

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

Terumo Advanced Perfusion System 1 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K221895. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Terumo Advanced Perfusion System 1?

Terumo Advanced Perfusion System 1 is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K221895.

When did Terumo Advanced Perfusion System 1 receive FDA 510(k) clearance?

Terumo Advanced Perfusion System 1 received FDA 510(k) clearance on 2023-04-18, under 510(k) number K221895.

Who is the listed applicant for Terumo Advanced Perfusion System 1?

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

What is the FDA product code for Terumo Advanced Perfusion System 1?

The FDA product code for Terumo Advanced Perfusion System 1 is DTQ.

列明Terumo Cardiovascular Systems 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。

K234065CDI OneView 监控系统 K200091Capiox iCP 离心泵 K182110CDI 血液参数监测系统 550 K180950Terumo Capiox NX19 储液式氧合器（东向），Terumo Capiox NX19 储液式氧合器（西向），Terumo Capiox NX19 氧合器（东向），Terumo Capiox NX19 氧合器（西向）K172071Terumo Capiox NX19 储液式氧合器（东向），Terumo Capiox NX19 储液式氧合器（西向），Terumo Capiox NX19 氧合器（东向），Terumo Capiox NX19 氧合器（西向）K172220高级灌注系统1

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官方来源

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