LiteSaber 线性扭矩辅助装置
K号: K200120 · 2020-05-07
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申请人Vesatek, LLC
决定日期2020-05-07
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]
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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
LiteSaber Wire Torque Assist Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesatek, LLC. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K200120. 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 LiteSaber Wire Torque Assist Device?
LiteSaber Wire Torque Assist Device is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Vesatek, LLC. The 510(k) number is K200120.
When did LiteSaber Wire Torque Assist Device receive FDA 510(k) clearance?
LiteSaber Wire Torque Assist Device received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200120.
Who is the listed applicant for LiteSaber Wire Torque Assist Device?
The FDA 510(k) record lists Vesatek, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LiteSaber Wire Torque Assist Device?
The FDA product code for LiteSaber Wire Torque Assist Device 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。
列明Vesatek, 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。
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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