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FDA 510(k)

Aristotle 14 导丝；Aristotle 18 导丝；Aristotle 24 导丝；Zoom Wire 14 导丝；Aristotle Colossus 导丝

K号: K243938 · 2025-04-01

申请人Scientia Vascular, Inc.
决定日期2025-04-01
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 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; 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 2025-04-01 under 510(k) number K243938. 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 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Scientia Vascular, Inc.. The 510(k) number is K243938.

When did Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire receive FDA 510(k) clearance?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire received FDA 510(k) clearance on 2025-04-01, under 510(k) number K243938.

Who is the listed applicant for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; 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 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire?

The FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire is MOF.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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K242301Socrates 38 导管K223913Socrates 吸引系统K223560Plato 17 微导管

查看所有 9 个设备 →

相关器械（代码：MOF）

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。

K254181亚里士多德65宏线Scientia VascularK26075135螺旋导丝Piraeus Medical, Inc.K262424Willow 12 导丝Arbor Endovascular, LLCK260223亚里士多德迷你导丝Scientia Vascular, Inc.K254006Drivewire 35 导丝Rapid Medical Ltd.K253579Aristotle 14 导丝；Aristotle 18 导丝；Aristotle 24 导丝；Zoom Wire 14 导丝Scientia Vascular, Inc.

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。

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