SureAx-Guide®
K号: K250203 · 2025-10-17
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决定日期2025-10-17
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
SureAx-Guide™ is the device name listed in this FDA 510(k) record. The listed applicant is Sureax Medical, LLC. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250203. 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 SureAx-Guide™?
SureAx-Guide™ is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Sureax Medical, LLC. The 510(k) number is K250203.
When did SureAx-Guide™ receive FDA 510(k) clearance?
SureAx-Guide™ received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250203.
Who is the listed applicant for SureAx-Guide™?
The FDA 510(k) record lists Sureax Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SureAx-Guide™?
The FDA product code for SureAx-Guide™ 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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