FDA 510(k)

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP 导管

K号: K261825 · 2026-07-02

申请人Abbott

决定日期2026-07-02

产品代码DQY

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 TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261825. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter?

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Abbott. The 510(k) number is K261825.

When did Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter receive FDA 510(k) clearance?

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261825.

Who is the listed applicant for Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter?

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

What is the FDA product code for Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter?

The FDA product code for Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter is DQY.

列明Abbott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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