免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Aristotle 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

K号: K173235 · 2018-01-22

申请人Scientia Vascular, LLC
决定日期2018-01-22
产品代码DQX
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, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile 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 2018-01-22 under 510(k) number K173235. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile?

Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile is a medical device that received FDA 510(k) clearance on 2018-01-22. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K173235.

When did Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile receive FDA 510(k) clearance?

Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile received FDA 510(k) clearance on 2018-01-22, under 510(k) number K173235.

Who is the listed applicant for Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile?

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, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile?

The FDA product code for Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile is DQX.

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, 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。

K220398Aristotle 14 导丝；Aristotle 18 导丝；Aristotle 24 导丝；Volo 14 导丝；Zoom Wire 14 导丝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

查看所有 8 个设备 →

相关器械（代码：DQX）

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。

K253146超驱动 35 导丝Rapid-Medical , Ltd.K261281CROSSLEAD 标准型 035 和 CROSSLEAD 硬度型 035Filmecc Co., Ltd.K253667Accoat 导丝Sp Medical A/SK261640卓越医疗MAK镍钛/金钨导丝Merit Medical Ireland , Ltd.K254137InQwire Amplatz导丝Merit Medical Ireland, Ltd.K260544FMD 外周导丝 F-14 弯曲 6; FMD 外周导丝 F-14 锥形 40; FMD 外周导丝 F-18 弯曲 SP; FMD 外周导丝 F-18 DP 25; FMD 外周导丝 F-18 锥形 40FMD Co., Ltd.

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。

↑