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FDA 510(k)

Diamonback 360 外周轨道动脉粥样硬化系统，Stealth 360 外周轨道动脉粥样硬化系统，Diamonback 360 外周轨道动脉粥样硬化系统 可交换系列

K号: K220568 · 2022-04-27

申请人Cardiovascualr Systems, Inc.
决定日期2022-04-27
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, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascualr Systems, Inc.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220568. 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, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series?

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Cardiovascualr Systems, Inc.. The 510(k) number is K220568.

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

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220568.

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

The FDA 510(k) record lists Cardiovascualr 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, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series?

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

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：MCW）

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。

K260244Auryon 激光旋切系统Eximo MedicalK250723FreedomFlow®轨道环形动脉粥样硬化系统（H6005/ 4Fr 3球配置）Cardio Flow Inc.,K250385Turbo-Elite 激光动脉粥样硬化切除术导管SpectraneticsK242757Rotarex 激光消融系统Bard Peripheral Vascular, Inc.K242947FreedomFlow®轨道环形动脉粥样硬化系统Cardio Flow Inc.,K241553Auryon 搔刮导管 1.7mm；Auryon 搔刮导管 1.7mm，亲水涂层Eximo Medical, Ltd.

官方来源

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