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FDA 510(k)

CrossWise RF 经隔膜通路系统（型号：CW-1085S, CW-1085A, CW-1012W, CW-1012C）；CrossWise RF 适配器电缆（型号 CW-1002）

K号: K241414 · 2024-09-26

申请人Circa Scientific, Inc.
决定日期2024-09-26
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

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241414. 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 CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K241414.

When did CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) receive FDA 510(k) clearance?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241414.

Who is the listed applicant for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

The FDA 510(k) record lists Circa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

The FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) 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

列明Circa Scientific, Inc.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。

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）K243954PeriCross™ 心外膜通路套件K243193Cross Wise® 多用 RF 适配器电缆K240004CardioCurve 可弯曲鞘 小卷曲，40cm (CC-1040S)；CardioCurve 可弯曲鞘 中卷曲，40cm (CC-1040M)；CardioCurve 可弯曲鞘 大卷曲，40cm (CC-1040L)；CardioCurve 可弯曲鞘 小卷曲，61cm (CC-1061S)；CardioCurve 可弯曲鞘 中卷曲，61cm (CC-1061M)；CardioCurve 可弯曲鞘 大卷曲，61cm (CC-1061L)；CardioCurve 可弯曲鞘 小卷曲，71cm (CC-1071S)；CardioCurve 可弯曲鞘 中卷曲，71cm (CC-1071M)；CardioCurve 可弯曲鞘K222311CIRCA MATRIX12 M 食管温度探头和温度监控系统

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。

K261745LightningWire经隔膜穿刺系统（TPS）ElectroWire MedicalK253799SafeSept 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.

官方来源

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