FDA 510(k)

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

K号: K220398 · 2023-03-10

决定日期2023-03-10

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; Volo 14 Guidewire; Zoom Wire 14 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K220398. 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; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K220398.

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

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire received FDA 510(k) clearance on 2023-03-10, under 510(k) number K220398.

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

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

What is the FDA product code for Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire?

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

列明Scientia Vascular, LLC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。

K210601Plato 17 微导管 K201760Zoom 14 导丝 K192783Aristotle 24 导丝，200cm，软型；Aristotle 24 导丝，200cm，标准型；Aristotle 24 导丝，200cm，支撑型 K183608Aristotle 18 导丝，200cm，软型；Aristotle 18 导丝，200cm，标准型；Aristotle 18 导丝，200cm，支撑型 K181828Volo 14 导丝，200cm，软型轮廓，Volo 14 导丝，200cm，标准轮廓，Volo 14 导丝，300cm，软型轮廓，Volo 14 导丝，300cm，标准轮廓 K173235Aristotle 14 导丝，200cm，软型，Aristotle 14 导丝，200cm，支撑型，Aristotle 14 导丝，300cm，软型，Aristotle 14 导丝，300cm，支撑型

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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。