HawkOne定向旋切系统
K号: K161361 · 2016-10-14
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决定日期2016-10-14
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：
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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]
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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
HawkOne Directional Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161361. 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 HawkOne Directional Atherectomy System?
HawkOne Directional Atherectomy System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K161361.
When did HawkOne Directional Atherectomy System receive FDA 510(k) clearance?
HawkOne Directional Atherectomy System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161361.
Who is the listed applicant for HawkOne Directional Atherectomy System?
The FDA 510(k) record lists Medtronic Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HawkOne Directional Atherectomy System?
The FDA product code for HawkOne Directional Atherectomy System 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。
列明Medtronic 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。
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
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。
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