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FDA 510(k)

LightningWire经隔膜穿刺系统（TPS）

K号: K261745 · 2026-06-26

申请人ElectroWire Medical
决定日期2026-06-26
产品代码DXF
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

LightningWire Transseptal Puncture System (TPS) is the device name listed in this FDA 510(k) record. The listed applicant is ElectroWire Medical. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K261745. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LightningWire Transseptal Puncture System (TPS)?

LightningWire Transseptal Puncture System (TPS) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is ElectroWire Medical. The 510(k) number is K261745.

When did LightningWire Transseptal Puncture System (TPS) receive FDA 510(k) clearance?

LightningWire Transseptal Puncture System (TPS) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K261745.

Who is the listed applicant for LightningWire Transseptal Puncture System (TPS)?

The FDA 510(k) record lists ElectroWire Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LightningWire Transseptal Puncture System (TPS)?

The FDA product code for LightningWire Transseptal Puncture System (TPS) is DXF.

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

相关器械（代码：DXF）

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。

K253799SafeSept RF 经隔膜导丝（SSRF132；SSRF132R；SSRF232；SSRF232R；SSRF135；SSRF135R；SSRF235；SSRF235R）Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF 导丝（901XXX）；HOTWIRE RF 导丝（902XXX）Atraverse MedicalK252419HOTWIRE RF 导丝（901XXX）；HOTWIRE RF 导丝（902XXX）Atraverse Medical, Inc.K251007CrossWise RF 经隔膜通路系统（型号：CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F）Circa Scientific, Inc.K243193Cross Wise® 多用 RF 适配器电缆Circa Scientific, Inc.K242076VersaCross™射频导丝Baylis Medical Company

官方来源

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