FDA 510(k)

Amplatzer导丝

K号: K250031 · 2025-10-03

决定日期2025-10-03

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

Amplatzer Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K250031. 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 Amplatzer Guidewire?

Amplatzer Guidewire is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K250031.

When did Amplatzer Guidewire receive FDA 510(k) clearance?

Amplatzer Guidewire received FDA 510(k) clearance on 2025-10-03, under 510(k) number K250031.

Who is the listed applicant for Amplatzer Guidewire?

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 Amplatzer Guidewire?

The FDA product code for Amplatzer Guidewire 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。

K261729EnSite™ X EP系统 K262006EnSite™ X EP系统 K261631Amplatzer TorqVue 交换系统 K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)K260212EnSite™ X EP系统 K253907一次性射频消融电极

查看所有 60 个设备 →

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。