FDA 510(k)

Rotarex 激光消融系统

K号: K242757 · 2025-01-30

决定日期2025-01-30

产品代码MCW

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

Rotarex Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K242757. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rotarex Atherectomy System?

Rotarex Atherectomy System is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K242757.

When did Rotarex Atherectomy System receive FDA 510(k) clearance?

Rotarex Atherectomy System received FDA 510(k) clearance on 2025-01-30, under 510(k) number K242757.

Who is the listed applicant for Rotarex Atherectomy System?

FDA 510(k)记录将Bard Peripheral Vascular, Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Rotarex Atherectomy System?

The FDA product code for Rotarex Atherectomy System is MCW.

列明Bard Peripheral Vascular, 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。

K262571EnCor EnCompass™乳腺活检和组织移除系统 K260012UltraScore™ 焦点力PTA球囊 K252681EnCor EnCompass™乳腺活检和组织移除系统 K250032Marquee® 一次性核心活检仪器和仪器套件 K250219Dorado™ PTA 扩张球囊导管 K243642UltraCor™ Twirl™ 乳腺组织标记器

查看所有 18 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。