FDA 510(k)

机械导丝

K号: K221351 · 2022-12-19

决定日期2022-12-19

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

Mechanical Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) number K221351. 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 Mechanical Guidewire?

Mechanical Guidewire is a medical device that received FDA 510(k) clearance on 2022-12-19. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K221351.

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

Mechanical Guidewire received FDA 510(k) clearance on 2022-12-19, under 510(k) number K221351.

Who is the listed applicant for Mechanical Guidewire?

The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mechanical Guidewire?

The FDA product code for Mechanical Guidewire is DQX.

列明Baylis Medical Company, 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。

K251325VersaCross Connect™ 腱间扩张器 K241720VersaCross Connect™ 腱间扩张器 K231227SureFlex HD 可弯曲鞘，VersaCross HD 可弯曲鞘 K233647VersaCross Connect™ 腱间扩张器 K213898ProTrack 尾线 K213582Epicardial Access System

查看所有 18 个设备 →

官方来源

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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。