FDA 510(k)

PowerWire® 14 射频导丝套装

K号: K251158 · 2025-09-11

决定日期2025-09-11

产品代码PDU

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Unknown

器械摘要

PowerWire® 14 Radiofrequency Guidewire Kit is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251158. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

What is the PowerWire® 14 Radiofrequency Guidewire Kit?

PowerWire® 14 Radiofrequency Guidewire Kit is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Baylis Medical Technologies, Inc.. The 510(k) number is K251158.

When did PowerWire® 14 Radiofrequency Guidewire Kit receive FDA 510(k) clearance?

PowerWire® 14 Radiofrequency Guidewire Kit received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251158.

Who is the listed applicant for PowerWire® 14 Radiofrequency Guidewire Kit?

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

What is the FDA product code for PowerWire® 14 Radiofrequency Guidewire Kit?

The FDA product code for PowerWire® 14 Radiofrequency Guidewire Kit is PDU.

列明Baylis Medical Technologies, 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。

K254114Baylis 连接器电缆 K250275PrecisePath® Radiofrequency Puncture Generator and PrecisePath® Footswitch K232562PowerWire 射频导丝套装 K230571RFP-100A 连接电缆（一次性使用）

官方来源

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