FDA 510(k)

PreSep Oligon 氧合测定导管

K号: K160645 · 2016-06-16

决定日期2016-06-16

产品代码DQE

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

PreSep Oligon Oximetry Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160645. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PreSep Oligon Oximetry Catheter?

PreSep Oligon Oximetry Catheter is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K160645.

When did PreSep Oligon Oximetry Catheter receive FDA 510(k) clearance?

PreSep Oligon Oximetry Catheter received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160645.

Who is the listed applicant for PreSep Oligon Oximetry Catheter?

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

What is the FDA product code for PreSep Oligon Oximetry Catheter?

The FDA product code for PreSep Oligon Oximetry Catheter is DQE.

列明Edwards Lifesciences, LLC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。

K251326呼吸频率算法 K253186HemoSphere Nano监测仪（HSNANO1）K251982Edwards MC3 三尖瓣成形环（4900）K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518高血压预测指数（HePI）算法 K242909FloTrac 传感器；FloTrac Jr 传感器；Acumen IQ 传感器；VolumeView 传感器

查看所有 53 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。