VersaCross™射频导丝
K号: K242076 · 2024-11-01
广告
决定日期2024-11-01
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
VersaCross™ RF Wire is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242076. 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 VersaCross™ RF Wire?
VersaCross™ RF Wire is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Baylis Medical Company. The 510(k) number is K242076.
When did VersaCross™ RF Wire receive FDA 510(k) clearance?
VersaCross™ RF Wire received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242076.
Who is the listed applicant for VersaCross™ RF Wire?
The FDA 510(k) record lists Baylis Medical Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VersaCross™ RF Wire?
The FDA product code for VersaCross™ RF Wire 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。
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
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。
广告