FDA 510(k)

Octane 吸引系统

K号: K173266 · 2017-12-01

决定日期2017-12-01

产品代码QEZ

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

Octane aspiration system is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K173266. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Octane aspiration system?

Octane aspiration system is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K173266.

When did Octane aspiration system receive FDA 510(k) clearance?

Octane aspiration system received FDA 510(k) clearance on 2017-12-01, under 510(k) number K173266.

Who is the listed applicant for Octane aspiration system?

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

What is the FDA product code for Octane aspiration system?

The FDA product code for Octane aspiration system is QEZ.

列明Vascular Solutions, 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。

K182232Octane机械血栓切除术系统 K181647Bandit 导丝 K180913VSI 微导管套装 K180088陷阱线导管 K180128战士14导丝 K173891Gel-Bead (600-800 micron) - 1 ml 球体体积, Gel-Bead (600-800 micron) - 2 ml 球体体积

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官方来源

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