FDA 510(k)

Sprinter传奇快速交换球囊扩张导管

K号: K251970 · 2026-01-17

决定日期2026-01-17

产品代码LOX

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

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Ireland. It received FDA 510(k) clearance on 2026-01-17 under 510(k) number K251970. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2026-01-17. The listed applicant is Medtronic, Ireland. The 510(k) number is K251970.

When did Sprinter Legend Rapid Exchange Balloon Dilatation Catheter receive FDA 510(k) clearance?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter received FDA 510(k) clearance on 2026-01-17, under 510(k) number K251970.

Who is the listed applicant for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

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

What is the FDA product code for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

The FDA product code for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is LOX.

列明Medtronic, Ireland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。

K261428NC Euphora 快速交换球囊扩张导管 K261759Euphora快速交换（RX）球囊扩张导管 K252390Telescope 导丝延长导管 K250787Liberant血栓切除术系统

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。