FDA 510(k)

HOTWIRE RF 导丝（901XXX）；HOTWIRE RF 导丝（902XXX）

K号: K252419 · 2025-08-27

决定日期2025-08-27

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

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is the device name listed in this FDA 510(k) record. The listed applicant is Atraverse Medical, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K252419. 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 HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Atraverse Medical, Inc.. The 510(k) number is K252419.

When did HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) receive FDA 510(k) clearance?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) received FDA 510(k) clearance on 2025-08-27, under 510(k) number K252419.

Who is the listed applicant for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

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

What is the FDA product code for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

The FDA product code for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is DXF.

列明Atraverse Medical, 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。

K252083HOTWIRE® 系统射频发生器和脚踏开关（可选配件）

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 Medical K253799SafeSept RF 经隔膜导丝（SSRF132；SSRF132R；SSRF232；SSRF232R；SSRF135；SSRF135R；SSRF235；SSRF235R）Pressure Products Medical Device Manufacturing, LLC K260292HOTWIRE RF 导丝（901XXX）；HOTWIRE RF 导丝（902XXX）Atraverse Medical 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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