FDA 510(k)

延长型单件动脉（EOPA）3D® 动脉导管

K号: K260195 · 2026-04-23

决定日期2026-04-23

产品代码DWF

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

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K260195. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Medtronic, Inc.. The 510(k) number is K260195.

When did Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae receive FDA 510(k) clearance?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae received FDA 510(k) clearance on 2026-04-23, under 510(k) number K260195.

Who is the listed applicant for Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

FDA 510(k)记录中列出Medtronic, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

The FDA product code for Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is DWF.

列明Medtronic, 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。

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