SION blue PLUS
K号: K243733 · 2025-04-02
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决定日期2025-04-02
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
SION blue PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K243733. 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 SION blue PLUS?
SION blue PLUS is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K243733.
When did SION blue PLUS receive FDA 510(k) clearance?
SION blue PLUS received FDA 510(k) clearance on 2025-04-02, under 510(k) number K243733.
Who is the listed applicant for SION blue PLUS?
The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SION blue PLUS?
The FDA product code for SION blue PLUS is DQX.
列明Asahi Intecc Co., Ltd.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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