FDA 510(k)

ARTLINE

K号: K160448 · 2016-07-12

申请人Health Line International Corporation

决定日期2016-07-12

产品代码DQY

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

ARTLINE is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K160448. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARTLINE?

ARTLINE is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Health Line International Corporation. The 510(k) number is K160448.

When did ARTLINE receive FDA 510(k) clearance?

ARTLINE received FDA 510(k) clearance on 2016-07-12, under 510(k) number K160448.

Who is the listed applicant for ARTLINE?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTLINE?

The FDA product code for ARTLINE is DQY.

列明Health Line International 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。

K261950Health Line 可撕开引导器 K222170功率急性三腔血液透析导管 K200426急性双腔血液透析导管 K200263Health Line CT 中线导管 K192533Health Line CT CVC

官方来源

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