FDA 510(k)

Aristotle 18 导丝；Aristotle 24 导丝

K号: K231954 · 2023-08-01

决定日期2023-08-01

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 18 Guidewire; Aristotle 24 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 2023-08-01 under 510(k) number K231954. 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 18 Guidewire; Aristotle 24 Guidewire?

Aristotle 18 Guidewire; Aristotle 24 Guidewire is a medical device that received FDA 510(k) clearance on 2023-08-01. The listed applicant is Scientia Vascular, Inc.. The 510(k) number is K231954.

When did Aristotle 18 Guidewire; Aristotle 24 Guidewire receive FDA 510(k) clearance?

Aristotle 18 Guidewire; Aristotle 24 Guidewire received FDA 510(k) clearance on 2023-08-01, under 510(k) number K231954.

Who is the listed applicant for Aristotle 18 Guidewire; Aristotle 24 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 18 Guidewire; Aristotle 24 Guidewire?

The FDA product code for Aristotle 18 Guidewire; Aristotle 24 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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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。