FDA 510(k)

Diamonback 360 外周轨道动脉粥样硬化系统可交换系列

K号: K182397 · 2018-12-13

决定日期2018-12-13

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

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182397. 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 Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series?

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K182397.

When did Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series receive FDA 510(k) clearance?

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182397.

Who is the listed applicant for Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series?

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

What is the FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series?

The FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is MCW.

列明Cardiovascular Systems, 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。

K220109DIAMONDBACK 360 外周轨道血管成形术系统，DIAMONDBACK 360 外周轨道血管成形术系统，可交换系列，Stealth 360 外周轨道血管成形术系统 K212725ViperCross 支撑导丝导管 K210586Diamonback 360 外周轨道动脉粥样硬化系统，Diamondback 360 隐形轨道动脉粥样硬化系统 K211240ViperCross 支撑导丝导管 K211251ViperCath XC 外周交换导管 K210282WIRION 颗粒保护系统

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官方来源

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