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FDA 510(k)

FMD 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 40

K号: K260544 · 2026-03-20

申请人FMD Co., Ltd.
决定日期2026-03-20
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

FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 is the device name listed in this FDA 510(k) record. The listed applicant is FMD Co., Ltd.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K260544. 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 FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40?

FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is FMD Co., Ltd.. The 510(k) number is K260544.

When did FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 receive FDA 510(k) clearance?

FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260544.

Who is the listed applicant for FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40?

The FDA 510(k) record lists FMD Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40?

The FDA product code for FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 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FMD 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。

K240460FMD 外周导丝 F-18 弯曲 400 (CSU415400259)K212268FMD 外周导丝 F-14 和 F-18, FMD 导丝延长器 F-14 EXT

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.K253746Enroute 0.014'' 转颈动脉导丝Lake Region Medical

官方来源

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