FDA 510(k)

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

K号: K250552 · 2025-07-25

决定日期2025-07-25

产品代码DQX

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

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K250552. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K250552.

When did Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire receive FDA 510(k) clearance?

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire received FDA 510(k) clearance on 2025-07-25, under 510(k) number K250552.

Who is the listed applicant for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

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

What is the FDA product code for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire?

The FDA product code for Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire is DQX.

列明ABBOTT MEDICAL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。

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官方来源

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