FDA 510(k)

Aristotle Colossus 导丝

K号: K222437 · 2023-01-26

决定日期2023-01-26

产品代码MOF

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

Aristotle Colossus Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K222437. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aristotle Colossus Guidewire?

Aristotle Colossus Guidewire is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Scientia Vascular, Inc.. The 510(k) number is K222437.

When did Aristotle Colossus Guidewire receive FDA 510(k) clearance?

Aristotle Colossus Guidewire received FDA 510(k) clearance on 2023-01-26, under 510(k) number K222437.

Who is the listed applicant for Aristotle Colossus Guidewire?

FDA 510(k)记录将Scientia Vascular, Inc.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Aristotle Colossus Guidewire?

The FDA product code for Aristotle Colossus Guidewire is MOF.

列明Scientia Vascular, 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。

K260223亚里士多德迷你导丝 K260002索福克勒斯吸痰系统（索福克勒斯70吸痰导管）K253579Aristotle 14 导丝；Aristotle 18 导丝；Aristotle 24 导丝；Zoom Wire 14 导丝 K243938Aristotle 14 导丝；Aristotle 18 导丝；Aristotle 24 导丝；Zoom Wire 14 导丝；Aristotle Colossus 导丝 K242301Socrates 38 导管 K223913Socrates 吸引系统

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官方来源

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