Radifocus Glidewire Advantage Track
K号: K163004 · 2017-01-30
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决定日期2017-01-30
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：
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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
Radifocus Glidewire Advantage Track is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Coporation. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K163004. 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 Radifocus Glidewire Advantage Track?
Radifocus Glidewire Advantage Track is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Ashitaka Factory of Terumo Coporation. The 510(k) number is K163004.
When did Radifocus Glidewire Advantage Track receive FDA 510(k) clearance?
Radifocus Glidewire Advantage Track received FDA 510(k) clearance on 2017-01-30, under 510(k) number K163004.
Who is the listed applicant for Radifocus Glidewire Advantage Track?
The FDA 510(k) record lists Ashitaka Factory of Terumo Coporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Radifocus Glidewire Advantage Track?
The FDA product code for Radifocus Glidewire Advantage Track 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。
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。
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