FDA 510(k)

InQwire Amplatz导丝

K号: K254137 · 2026-05-22

决定日期2026-05-22

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

InQwire Amplatz Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Ireland, Ltd.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K254137. 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 InQwire Amplatz Guide Wire?

InQwire Amplatz Guide Wire is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Merit Medical Ireland, Ltd.. The 510(k) number is K254137.

When did InQwire Amplatz Guide Wire receive FDA 510(k) clearance?

InQwire Amplatz Guide Wire received FDA 510(k) clearance on 2026-05-22, under 510(k) number K254137.

Who is the listed applicant for InQwire Amplatz Guide Wire?

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

What is the FDA product code for InQwire Amplatz Guide Wire?

The FDA product code for InQwire Amplatz Guide Wire is DQX.

列明Merit Medical Ireland, Ltd.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。

K261640卓越医疗MAK镍钛/金钨导丝 K253847Splashwire亲水导丝（MSWSTD35150J3）K251385InQwire超级刚性导丝（IQSS32180J3）；InQwire超级刚性导丝（IQSS35F260S）；InQwire超级刚性导丝（IQSS35F150S）；InQwire超级刚性导丝（IQSS35F100S）；InQwire超级刚性导丝（IQSS35F80S）；InQwire超级刚性导丝（IQSS35F180S）K251181Splashwire亲水导丝（MSWSTD35180J1O5）；Splashwire亲水导丝（MSWSTD35260J1O5）；Splashwire亲水导丝（MSWSTDA35150LT）；Splashwire亲水导丝（MSWSTFA35260LT）；Splashwire亲水导丝（MSWSTFA35150LT）；Splashwire亲水导丝（MSWSTFS38150LT）

官方来源

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