免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Terumo高级灌注系统1的小型（4）滚柱泵，大型（6）滚柱泵

K号: K162843 · 2016-11-17

申请人Terumo Cardiovascular Systems Corporation
决定日期2016-11-17
产品代码DWB
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

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the 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 2016-11-17 under 510(k) number K162843. The device is classified under product code DWB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1?

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K162843.

When did Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 receive FDA 510(k) clearance?

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162843.

Who is the listed applicant for Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the 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 Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1?

The FDA product code for Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 is DWB.

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K221895Terumo 先进灌注系统 1K200091Capiox iCP 离心泵K182110CDI 血液参数监测系统 550K180950Terumo 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）

查看所有 10 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑